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Adjusted P (adjusted + p)
Selected AbstractsRandomized Trial of a Delirium Abatement Program for Postacute Skilled Nursing FacilitiesJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 6 20100000], [See editorial comments by Dr. Steven A. Levenson on pp 0000 OBJECTIVES: To determine whether a delirium abatement program (DAP) can shorten duration of delirium in new admissions to postacute care (PAC). DESIGN: Cluster randomized controlled trial. SETTING: Eight skilled nursing facilities specializing in PAC within a single metropolitan region. PARTICIPANTS: Four hundred fifty-seven participants with delirium at PAC admission. INTERVENTION: The DAP consisted of four steps: assessment for delirium within 5 days of PAC admission, assessment and correction of common reversible causes of delirium, prevention of complications of delirium, and restoration of function. MEASUREMENTS: Trained researchers screened eligible patients. Those with delirium defined according to the Confusion Assessment Method were eligible for participation using proxy consent. Regardless of location, researchers blind to intervention status re-assessed participants for delirium 2 weeks and 1 month after enrollment. RESULTS: Nurses at DAP sites detected delirium in 41% of participants, versus 12% in usual care sites (P<.001), and completed DAP documentation in most participants in whom delirium was detected, but the DAP intervention had no effect on delirium persistence based on two measurements at 2 weeks (DAP 68% vs usual care 66%) and 1 month (DAP 60% vs usual care 51%) (adjusted P,.20). Adjusting for baseline differences between DAP and usual care participants and restricting analysis to DAP participants in whom delirium was detected did not alter the results. CONCLUSION: Detection of delirium improved at the DAP sites, but the DAP had no effect on the persistence of delirium. This effectiveness trial demonstrated that a nurse-led DAP intervention was not effective in typical PAC facilities. [source] Association of common genetic variation in the insulin/IGF1 signaling pathway with human longevityAGING CELL, Issue 4 2009Ludmila Pawlikowska Summary The insulin/IGF1 signaling pathways affect lifespan in several model organisms, including worms, flies and mice. To investigate whether common genetic variation in this pathway influences lifespan in humans, we genotyped 291 common variants in 30 genes encoding proteins in the insulin/IGF1 signaling pathway in a cohort of elderly Caucasian women selected from the Study of Osteoporotic Fractures (SOF). The cohort included 293 long-lived cases (lifespan , 92 years (y), mean ± standard deviation (SD) = 95.3 ± 2.2y) and 603 average-lifespan controls (lifespan , 79y, mean = 75.7 ± 2.6y). Variants were selected for genotyping using a haplotype-tagging approach. We found a modest excess of variants nominally associated with longevity. Nominally significant variants were then replicated in two additional Caucasian cohorts including both males and females: the Cardiovascular Health Study and Ashkenazi Jewish Centenarians. An intronic single nucleotide polymorphism in AKT1, rs3803304, was significantly associated with lifespan in a meta-analysis across the three cohorts (OR = 0.78 95%CI = 0.68,0.89, adjusted P = 0.043); two intronic single nucleotide polymorphisms in FOXO3A demonstrated a significant lifespan association among women only (rs1935949, OR = 1.35, 95%CI = 1.15,1.57, adjusted P = 0.0093). These results demonstrate that common variants in several genes in the insulin/IGF1 pathway are associated with human lifespan. [source] Demographic and risk factors in patients with head and neck tumorsJOURNAL OF MEDICAL VIROLOGY, Issue 5 2009Ruth Tachezy Abstract The association between human papillomavirus (HPV) infection and the development of head and neck cancer has been documented recently. In this study on 86 head and neck cancer patients and 124 controls, data regarding demographics, behavioral risk factors, and risks related to HPV exposure were collected. HPV detection was carried out using polymerase chain reaction in the tumors and in oral exfoliated cells, and HPV typing by a reverse line blot assay specific for 37 HPV types. Sera were tested by an enzyme-linked immunosorbent assay specific for HPV proteins. Head and neck cancer cases report significantly more oral-anal contact (P,=,0.02) and tobacco and alcohol use than controls (P,=,0.001; P,=,0.02, respectively). High-risk HPV DNA was detected in 43% of oral washings of cases and 4% of controls (P,<,0.0001). The association between the presence of high-risk HPV DNA in oral exfoliated cells and in tumor tissues was statistically significant (adjusted P,<,0.0001). The prevalence of HPV-specific antibodies was significantly higher in cases than in controls (adjusted P,<,0.0001). These results provide epidemiological and immunological evidence for HR HPV as a strong risk factor (OR,=,44.3, P,<,0.0001) for head and neck cancer, even after controlling for age, tobacco and alcohol use. The detection of high-risk HPV DNA in oral exfoliated cells and HPV-specific antibodies in serum can be considered as clinically relevant surrogate markers for the presence of a HPV-associated head and neck cancer, with a high sensitivity (83%) and specificity (88%). J. Med. Virol. 81:878,887, 2009. © 2009 Wiley-Liss, Inc. [source] Association of a KCNA5 gene polymorphism with systemic sclerosis,associated pulmonary arterial hypertension in the European Caucasian populationARTHRITIS & RHEUMATISM, Issue 10 2010J. Wipff Objective Pulmonary arterial hypertension (PAH) has emerged as a leading cause of death in systemic sclerosis (SSc). The genetic basis of PAH has been unraveled in recent years, with a major role played by transforming growth factor , receptors; however, some other candidate genes have also been advocated, including potassium voltage-gated channel, shaker-related subfamily, member 5 (KCNA5). We undertook this study to determine whether KCNA5 polymorphisms confer susceptibility to SSc and its vascular phenotype, including PAH. Methods Four KCNA5 single-nucleotide polymorphisms (SNPs), rs10744676, rs1860420, rs3741930, and rs2284136, were genotyped in a discovery set of 638 SSc patients and 469 controls. In addition, rs10744676 was genotyped in an independent replication sample (938 SSc patients and 564 controls) and in a cohort of 168 patients with different PAH subtypes. Results The KCNA5 rs10744676 variant was found to be associated with SSc in the discovery sample, with an odds ratio (OR) of 0.62 (95% confidence interval [95% CI] 0.48,0.79, adjusted P = 0.0003) in comparison with controls (C allele frequency 11.4% versus 17.2%). When subphenotypes were investigated, an association was found solely for PAH associated with SSc (OR 0.31 [95% CI 0.13,0.71], adjusted P = 0.04). The other KCNA5 SNPs tested were not associated with any SSc subset. The above association with PAH associated with SSc was replicated in the second set. In the combined population, rs10744676 was strongly associated with PAH associated with SSc in comparison with controls (OR 0.36 [95% CI 0.21,0.63], P = 0.0002). In the independent cohort of patients with PAH, after investigating PAH subtypes, only rs10744676 showed an association with PAH associated with SSc. Conclusion Our results provide the first evidence for an association between the KCNA5 rs10744676 variant and PAH associated with SSc. [source] A randomized, assessor-blind, parallel-group, multicentre, phase IV comparative trial of a suffocant compared with malathion in the treatment of head lice in childrenAUSTRALASIAN JOURNAL OF DERMATOLOGY, Issue 3 2010Kerryn A Greive ABSTRACT Background/Objectives:, There are concerns about the effectiveness of head lice treatments because of increasing resistance and safety. This trial compared the safety and efficacy of a suffocant-based head lice treatment to malathion in children. Methods:, The trial used strict entry criteria, standardized treatment and assessment regimens, sibling treatment where appropriate and a primary efficacy end-point defined as the absence of live head lice. Results:, A total of 216 children were enrolled. One hundred and sixty-nine were per-protocol. The suffocant was significantly more effective than malathion for the intention-to-treat population (53.9% vs 40.4% louse-free, unadjusted P = 0.052; adjusted P = 0.024), as well as for the per-protocol population (57.8% vs 43.0% louse-free, unadjusted P = 0.054; adjusted P = 0.045). Adverse events were limited to itching or stinging and there were no serious or systemic adverse events. Repeat insult patch testing with the suffocant resulted in no adverse reactions. In vitro tests confirmed that the suffocant is a potent ovicide and pediculicide with 100% mortality of eggs and lice following a 20-min contact time. Conclusions:, The suffocant is shown to be significantly more effective in eliminating head lice than malathion in children, while being associated with a low incidence of mild, transient adverse events. [source] Long-term data on the survival of patients with prostate cancer treated with radical prostatectomy in the prostate-specific antigen eraBJU INTERNATIONAL, Issue 1 2010Hendrik Isbarn Study Type , Therapy (case series) Level of Evidence 4 OBJECTIVE To examine the long-term rates of biochemical recurrence (BCR)-free survival, cancer-specific mortality (CSM)-free survival, and overall survival (OS) in patients with prostate cancer treated with open radical prostatectomy (RP) in the prostate-specific antigen (PSA) era. PATIENTS AND METHODS The study comprised 436 patients who were treated with RP between 1992 and 1997 at our institution. None received adjuvant/salvage therapy in the absence of BCR. The BCR-free, CSM-free and OS rates were defined using the Kaplan-Meier method. Multivariable Cox-regression models were used to test the effect of age, preoperative PSA level, neoadjuvant hormonal therapy, pT stage, lymph node status, RP Gleason sum and surgical margin status on BCR. RESULTS The median follow-up of censored patients was 122, 128, and 132 months for, respectively, BCR-free, CSM-free and OS estimates. The 10-year event-free survival rates for the same endpoints were 60%, 94% and 86%, respectively. Preoperative PSA level, RP Gleason sum, pT stage, lymph node status, and surgical margin status were independent predictors of BCR (all adjusted P < 0.05). CONCLUSIONS This study is the first to evaluate the long-term cancer control outcomes after RP from a European country in the PSA era. Our data indicate that RP provides excellent long-term survival rates in patients with clinically localized prostate cancer. Although ,40% of patients have BCR after 10 years of follow-up, the CSM rate after 10 years is as low as 6%. [source] Improved cardiovascular health following a progressive walking and dietary intervention for type 2 diabetesDIABETES OBESITY & METABOLISM, Issue 9 2009S. T. Johnson Aim: To examine the impact of two different lifestyle programmes on cardiovascular health and glycaemic control among people with type 2 diabetes. Methods: A two-phase 24-week randomized trial. During the first phase, participants were to increase daily steps using a pedometer. At week 12, participants were randomly allocated to either an enhanced lifestyle programme (ELP) targeting walking speed or a basic lifestyle programme (BLP) targeting total daily steps. Both programmes focused on increasing the intake of low glycaemic index foods but utilized different goal setting strategies. Clinical measurements were completed at baseline, week 12 and week 24. Principal outcomes were change in resting pulse rate (PR) and glycated haemoglobin A1c (A1c) between week 12 and week 24 compared between groups using analysis of covariance. Results: Forty-one participants [mean ± s.d. : age = 56.5 ± 7.2 years, body mass index (BMI) = 32.7 ± 6.1 kg/m2] were randomized. After 12 weeks, we observed an increase in average total daily steps of 1562 (95% confidence interval: 303,2821, p = 0.02). Weight, BMI and systolic and diastolic blood pressure improved (p < 0.01 for all). No changes were observed for energy intake. At week 24, those in the ELP had a lower resting PR (71 ± 12 b.p.m.) compared with those in the BLP (78 ± 12 b.p.m.) (adjusted p = 0.03), while no group differences for total daily steps or glycaemic control were observed. Conclusions: Improvements in cardiovascular health can be expected following a pedometer-based lifestyle modification programme that progresses from walking more to walking faster. [source] Refill adherence and polypharmacy among patients with type 2 diabetes in general practicePHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 11 2009Rykel van Bruggen PhD Abstract Background and Aims Non-adherence is considered a major barrier to better outcomes of diabetes care. A relationship has been established between polypharmacy and patients' adherence. This study aims to investigate the occurrence of polypharmacy and non-adherence in general practice, their mutual relationship and the association between adherence and the intermediate outcomes of diabetes care. Materials and Methods We used the baseline and follow-up data of a randomised controlled trial (RCT) that compared usual care with care in accordance with a locally adapted national guideline. This study took place in the Netherlands and involved 30 general practices and 1283 patients. We obtained a complete medication profile of all participants and calculated the number of prescribed drugs and the adherence indices (AI) for oral blood glucose, blood pressure and cholesterol lowering drugs. Patients with an adherence index <,0.8 were considered non-adherent. Clustering at practice level and case-mix were taken into account. Results Approximately 80% of the participating patients demonstrated an adherence index ,,0.8 for oral blood glucose, blood pressure and cholesterol lowering drugs. In the intervention group, increase of drug prescriptions exceeded that of controls (1.1,±,2.0 vs. 0.6,±,1.5, p,<,0.001, adjusted p,<,0.05). There was evidence of an inverse relationship between the number of drugs that had been prescribed during the last 6 months of the study and patients' adherence to blood pressure lowering medications (adjusted OR 0.84, 95%CI 0.78,0.91). After one year, HbA1c and total cholesterol levels were significantly lower in adherent patients. Conclusion During the intervention the mean number of drug prescriptions increased in both the study groups. This did not result in a lower adherence to blood glucose and cholesterol lowering medications. Given the relationship between the number of medications and patients' adherence to blood pressure lowering drugs, it may be wise to discuss adherence before prescribing multiple drug regimens. Copyright © 2009 John Wiley & Sons, Ltd. [source] The Transcriptome of the Implant Biopsy Identifies Donor Kidneys at Increased Risk of Delayed Graft FunctionAMERICAN JOURNAL OF TRANSPLANTATION, Issue 1 2008T. F. Mueller Improved assessment of donor organ quality at time of transplantation would help in management of potentially usable organs. The transcriptome might correlate with risk of delayed graft function (DGF) better than conventional risk factors. Microarray results of 87 consecutive implantation biopsies taken postreperfusion in 42 deceased (DD) and 45 living (LD) donor kidneys were compared to clinical and histopathology-based scores. Unsupervised analysis separated the 87 kidneys into three groups: LD, DD1 and DD2. Kidneys in DD2 had a greater incidence of DGF (38.1 vs. 9.5%, p < 0.05) than those in DD1. Clinical and histopathological risk scores did not discriminate DD1 from DD2. A total of 1051 transcripts were differentially expressed between DD1 and DD2, but no transcripts separated DGF from immediate graft function (adjusted p < 0.01). Principal components analysis revealed a continuum from LD to DD1 to DD2, i.e. from best to poorest functioning kidneys. Within DD kidneys, the odds ratio for DGF was significantly increased with a transcriptome-based score and recipient age (p < 0.03) but not with clinical or histopathologic scores. The transcriptome reflects kidney quality and susceptibility to DGF better than available clinical and histopathological scoring systems. [source] Earlier versus later continuous Kangaroo Mother Care (KMC) for stable low-birth-weight infants: a randomized controlled trialACTA PAEDIATRICA, Issue 6 2010S Nagai Abstract Aim:, The aim of this study was to examine the effectiveness of earlier continuous Kangaroo Mother Care (KMC) for relatively stable low-birth-weight (LBW) infants in a resource-limited country. Methods:, A randomized controlled trial was performed in LBW infants at a referral hospital in Madagascar. Earlier continuous KMC (intervention) was begun as soon as possible, within 24 h postbirth, and later continuous KMC (control: conventional care) was begun after complete stabilization (generally after 24 h postbirth). Main outcome measure was mortality during the first 28 days postbirth. This trial was registered with ClinicalTrials.gov, NCT00531492. Results:, A total of 73 infants (intervention 37, control 36) were included. Earlier continuous KMC had higher but no statistically different mortality in the first 28 days postbirth (1 vs. 2; risk ratio, 1.95; 95% CIs, 0.18,20.53; p = 1.00). There were no differences in incidence of morbidities. Body weight loss from birth to 24 h postbirth was significantly less in earlier KMC infants compared with later KMC infants. (,34.81 g vs. ,73.97 g; mean difference, 39.16 g; 95% CIs, 10.30,68.03; p = 0.01; adjusted p = 0.02). Adverse events and duration of hospitalization were not different between the two groups. Conclusions:, Further evaluations of earlier continuous KMC including measurement of KMC dose, are needed in resource-limited countries. [source] Association of polymorphisms in the human surfactant protein-D (SFTPD) gene and postnatal pulmonary adaptation in the preterm infantACTA PAEDIATRICA, Issue 1 2009Anne Hilgendorff Abstract Background. Surfactant protein-D (SP-D) is a member of the collagenous subfamily of calcium-dependent lectins (collectins). Associations between single nucleotide polymorphisms (SNPs) of the human gene coding surfactant protein-D (SFTPD) and infectious pulmonary diseases have been established by several groups. As the outcome of very preterm infants is mainly determined by pulmonary morbidity, the aim of the present study was to investigate the potential association between sequence variations within the SFTPD gene and pulmonary morbidity in preterm infants below 32 weeks of gestational age (GA). Materials and Results. Four validated SNPs were genotyped with sequence-specific probes (TaqMan 7000) in 284 newborn infants below 32 weeks of GA. An association between the SNP rs1923537 and the development of respiratory distress syndrome (RDS) in the study population was found with a lower prevalence of RDS in infants having homozygous a minor allele genotype (odds ratio = 1.733, 95% confidence interval 1.139,2.636, adjusted p = 0.0408). Consecutively, the indicated polymorphism was found to be associated with a lower number of repetitive surfactant doses, and with a lower prevalence for the requirement of oxygen supplementation on day 28, as well as the use of diuretics. Conclusion. The finding of an association of a variant of the SFTPD gene, that has previously been shown to be associated with increased SP-D serum levels in adult patients with acute respiratory failure, i.e. RDS in preterm infants, may provide a basis for the initial risk assessment of RDS and modification of surfactant treatment strategies. A role for SP-D in neonatal pulmonary adaptation has to be postulated. [source] | |||||||||||||