Abstract Context A validated 82-item Advance Care Planning (ACP) Engagement Survey measures a broad range of behaviors. However, concise surveys are needed. Objectives The objective of this study was ...to validate shorter versions of the survey. Methods The survey included 57 process (e.g., readiness) and 25 action items (e.g., discussions). For item reduction, we systematically eliminated questions based on face validity, item nonresponse, redundancy, ceiling effects, and factor analysis. We assessed internal consistency (Cronbach's alpha) and construct validity with cross-sectional correlations and the ability of the progressively shorter survey versions to detect change one week after exposure to an ACP intervention (Pearson correlation coefficients). Results Five hundred one participants (four Canadian and three US sites) were included in item reduction (mean age 69 years ±10, 41% nonwhite). Because of high correlations between readiness and action items, all action items were removed. Because of high correlations and ceiling effects, two process items were removed. Successive factor analysis then created 55-, 34-, 15-, nine-, and four-item versions; 664 participants (from three US ACP clinical trials) were included in validity analysis (age 65 years ±8, 72% nonwhite, 34% Spanish speaking). Cronbach's alphas were high for all versions (four items 0.84–55 items 0.97). Compared with the original survey, cross-sectional correlations were high (four items 0.85; 55 items 0.97) as were delta correlations (four items 0.68; 55 items 0.93). Conclusion Shorter versions of the ACP Engagement Survey are valid, internally consistent, and able to detect change across a broad range of ACP behaviors for English and Spanish speakers. Shorter ACP surveys can efficiently measure broad ACP behaviors in research and clinical settings.
Abstract Background Patients with chronic heart failure (CHF) secondary to left ventricular (LV) systolic dysfunction (LVSD) are frequently deficient in vitamin D. Low vitamin D levels are associated ...with a worse prognosis. It is unclear whether vitamin D deficiency is a marker of disease severity or plays a pathophysiological role. Objectives The VitamIN D treatIng patients with Chronic heArT failurE (VINDICATE) study was designed to establish the safety and efficacy of high-dose vitamin D supplementation in patients with CHF due to LVSD. Methods We enrolled 229 patients (179 men) with CHF due to LVSD and vitamin D deficiency ((25(OH) vitamin D3 <50nmol/L (<20ng/mL)) into a randomised, placebo-controlled double-blind trial of vitamin D supplementation. Participants were either allocated to one year of vitamin D3 supplementation (4000IU (100μg) 25(OH)D3 daily) or matching non-calcium-based placebo. The primary endpoint was change in six-minute walk distance from baseline to 12 months. Pre-specified secondary endpoints included change in left ventricular ejection fraction at one year, and safety measures of renal function and serum calcium concentration assessed every three months. Results One year of high-dose vitamin D supplementation did not improve 6-minute walk distance at one year, but was associated with a significant improvement in cardiac function on echocardiography (left ventricular ejection fraction +6.07% (95% CI 3.20, 8.95; p<0.0001); and a reversal of left ventricular remodeling (left ventricular end diastolic diameter -2.49mm (95% CI -4.09, -0.90; p=0.002) and left ventricular end systolic diameter -2.09mm (95% CI -4.11; -0.06 p=0.043). There were no clinically significant effects on calcium levels or renal function. Conclusions One year of 100μg daily 25-OH vitamin D3 supplementation does not improve 6-minute walk distance but has beneficial effects on LV structure and function in patients on contemporary optimal medical therapy. Further studies are necessary to determine whether these translate to improvements in outcomes.
Background IL-13 is a key TH 2 cytokine that is implicated in allergic responses. Objective We evaluated the effects of an anti–IL-13–blocking antibody compared with placebo on repeated nasal ...allergen challenge responses in hay fever patients out of season. Methods We performed a parallel group double-blind study of anti–IL-13 (single dose, 6 mg/kg intravenously, n = 16) and placebo (n = 15), with an additional open label group given a topical nasal corticosteroid (n = 5). Subjects received intranasal timothy grass pollen ( Phleum pratense P5 allergen), and serial samples of nasal mucosal lining fluid were taken by using synthetic absorptive matrix and by nasal lavage. Results Administration of anti–IL-13 on day 1 resulted in a significant decrease in IL-13 levels in synthetic absorptive matrix eluates compared with placebo (area under the curve 0-8 hours, change from baseline) during the late phase after nasal allergen challenge on day 5 ( P < .05) and day 7 ( P < .01). There were no apparent effects of anti–IL-13 treatment on nasal lavage eosinophil numbers or total nasal symptom scores versus placebo. However, in a subgroup with high late-phase IL-13 levels at screening, there was a trend for a decrease in total nasal symptom scores after nasal allergen challenge on day 5, when compared with subjects with low IL-13 levels ( P < .10). Nasal fluticasone caused suppression of IL-13 ( P < .05 on day 5) as well as IL-5 ( P < .01 on day 5) levels in the late phase compared with placebo. Conclusions Anti–IL-13 had specific pharmacodynamic action in this nasal allergen challenge model, causing profound inhibition of nasal lining fluid IL-13 responses. In addition, there was a possible effect of anti–IL-13 treatment on total nasal symptom scores in a subgroup with high late-phase nasal IL-13 levels at screening.
This cross-sectional study examines the association between disability, dementia, and depression and engagement in meaningful activities in community-dwelling older adults.
An abstract of a study by Sudore et al describing the results of a randomized control trial comparing the ACP PREPARE website plus an easy-to-read advance directive to an easy-to-read advance ...directive alone is presented. The purely patient-facing, ACP PREPARE website plus an easy-to-read advance directive compared to a directive alone increased ACP documentation and engagement among diverse older adults.
Background Smoking cessation is of major importance for all smokers; however, in patients with COPD, little information exists on how smoking cessation influences lung function and high-resolution CT ...(HRCT) scan appearances. Methods In this single-center study, we performed screening spirometry in a group of heavy smokers aged 40 to 80 years (N = 358). We then studied the effects of smoking cessation in two groups of selected subjects: smokers with COPD (n = 38) and smokers with normal spirometry (n = 55). In parallel to subjects undergoing smoking cessation, we studied a control group of nonsmokers (n = 19). Results Subjects with COPD who quit smoking had a marked, but transient improvement in FEV1 at 6 weeks (184 mL, n = 17, P < .01) that was still present at 12 weeks (81 mL, n = 17, P < .05) and only partially maintained at 1 year. In contrast, we saw improvement in the transfer factor of lung for carbon monoxide at 6 weeks in both subjects with COPD who quit smoking (0.47 mmol/min/kPa, n = 17, P < .01) and subjects who quit smoking with normal spirometry (0.40 mmol/min/kPa, n = 35, P < .01). An upper-zone single HRCT image slice reliably identified emphysema at baseline in 74% of smokers with COPD (28 of 38) and 29% of healthy smokers (16 of 55). Smoking cessation had no significant effect on the appearances of emphysema but decreased the presence of micronodules on HRCT imaging. Conclusions Cigarette smoking causes extensive lung function and HRCT image abnormalities, even in patients with normal spirometry. Smoking cessation has differential effects on lung function (FEV1 and gas transfer) and features on HRCT images (emphysema and micronodules). Cessation of smoking in patients with COPD causes a transient improvement in FEV1 and decreases the presence of micronodules, offering an opportunity for concomitant therapy during smoking cessation to augment these effects. Smoking cessation at the earliest possible opportunity is vital to minimize permanent damage to the lungs.
Summary Background Antiviral drugs are a proposed medical intervention to reduce household transmission of influenza viruses. In a previously described randomised, placebo-controlled trial in Dhaka, ...Bangladesh, we showed that oseltamivir treatment of index patients was able to reduce influenza symptom duration and virus shedding. In a further analysis that is part of the same study, we aimed to assess efficacy of oseltamivir to reduce secondary household illnesses in the same cohort. Methods In this double-blind oseltamivir efficacy trial, we identified index patients aged older than 1 year through surveillance of households in Dhaka, Bangladesh. We randomly allocated eligible patients (1:1) to receive oseltamivir or placebo twice-daily for 5 days, and we stratified them by enrolment 48 h versus 48–120 h since illness onset. Participants provided nasal wash specimens at enrolment and 2, 4, and 7 days after enrolment and were visited daily by a research assistant to record symptoms, both in index patients and in household members. For this part of the study, household members were asked to give respiratory specimens for influenza PCR testing. Our primary outcomes were household secondary illness and PCR-confirmed influenza virus infection, assessed in household members of all randomly allocated index patients. This trial is registered with ClinicalTrials.gov , number NCT00707941. Findings From May 11, 2008, to Dec 31, 2010, we enrolled 1190 index patients with 4694 household members. 592 patients were allocated to placebo (2292 household members) and 598 to oseltamivir (2402 household members). Household secondary illness was lower in the oseltamivir group (196 8% influenza cases) than in the placebo group (233 10%; odds ratio OR 0·77, 95% CI 0·60–0·98, p=0·031). PCR-confirmed influenza virus infection did not differ between the placebo (103 5%) and oseltamivir groups (92 4%; 0·84, 0·59–1·19, p=0·319); however, only 243 (57%) of ill household members gave a specimen for analysis. Interpretation In a crowded, low income setting, oseltamivir treatment of index patients resulted in a small reduction of secondary influenza in their households. Even this slight reduction, in the setting of widespread antiviral use during a community influenza outbreak, might result in reductions in overall disease burden. Funding Centers for Disease Control and Prevention (in an agreement with the International Centre for Diarrhoeal Disease Research, Bangladesh).
An abstract of a study by Sudore et al describing a systematic process to reduce survey items on the validated Advance Care Planning Engagement Survey is presented. Shorter versions of the ACP ...Engagement Survey are valid, internally consistent, and able to detect change across a broad range of ACP behaviors for English and Spanish speakers.
Background Helminth infections are associated with protection against allergies. It is postulated that IL-10 production after helminth infection suppresses skin hypersensitivity and increases IgG4 ...production, protecting against allergies. Objective We aimed to determine whether IL10 polymorphisms are associated with helminth infection and the risk of wheeze and allergy. Methods Twelve IL10 single nucleotide polymorphisms were genotyped in 1353 children aged 4 to 11 years living in a poor urban area in Salvador, Brazil. Wheezing status, Ascaris lumbricoides and Trichuris trichiura infection, IL-10 production by peripheral blood leukocytes stimulated with A lumbricoides extract, serum total IgE levels, specific IgE levels, skin prick test responses to common aeroallergens, and IgG4 and IgE anti– A lumbricoides antibody levels were measured in all children. Association tests were performed by using logistic or linear regression when appropriate, including sex, age, helminth infection, and principal components for ancestry informative markers as covariates by using PLINK. Results Allele G of marker rs3024496 was associated with the decreased production of IL-10 by peripheral blood leukocytes in response to A lumbricoides stimulation. Allele C of marker rs3024498 was negatively associated with helminth infection or its markers. Marker rs3024492 was positively associated with the risk of atopic wheeze, total IgE levels, and skin prick test responses to cockroach. Conclusions Our findings suggest that IL10 polymorphisms might play a role in the production of IL-10, helminth infection, and allergy. We hypothesize that polymorphisms related to protection against helminths, which would offer an evolutionary advantage to subjects in the past, might be associated with increased risk of allergic diseases.
Background Meta-analyses of randomized trials show that primary percutaneous coronary intervention (PPCI) results in lower mortality than fibrinolytic therapy in patients with myocardial infarction. ...We investigated which categories of patients with myocardial infarction would benefit most from the strategy of PPCI and, thus, have lowest numbers needed to treat to prevent a death. Methods Individual patient data were obtained from 22 (n = 6,763) randomized trials evaluating efficacy and safety of PPCI versus fibrinolysis. A risk score was developed and validated to estimate the probability of 30-day death in individuals. Patients were then divided in quartiles according to risk. Subsequent analyses were performed to evaluate if the treatment effect was modified by estimated risk. Results Overall, 446 patients (6.6%) died within 30 days after randomization. The mortality risk score contained clinical characteristics, including the time from symptom onset to randomization. The c-index was 0.76, and the Hosmer-Lemeshow test was nonsignificant, reflecting adequate discrimination and calibration. Patients randomized to PPCI had lower mortality than did patients randomized to fibrinolysis (5.3% vs 7.9%, adjusted odds ratio 0.63, 95% CI 0.42-0.84, P < .001). The interaction between risk score and allocated treatment interaction term had no significant contribution ( P = .52) to the model, indicating that the relative mortality reduction by PPCI was similar at all levels of estimated risk. In contrast, the absolute risk reduction was strongly related to estimated risk at baseline: the numbers needed to treat to prevent a death by PPCI versus fibrinolysis was 516 in the lowest quartile of estimated risk compared with only 17 in the highest quartile. Conclusion Primary percutaneous coronary intervention is consistently associated with a strong relative reduction in 30-day mortality, irrespective of patient baseline risk, and should therefore be considered as the first choice reperfusion strategy whenever feasible. If access to percutaneous coronary intervention is >2 hours, fibrinolysis remains a legitimate option in low-risk patients because of the small absolute risk reduction by PPCI in this particular cohort.
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