Risk Odds Ratio Research Articles

Safety and Efficacy of Tumor Necrosis Factor Antagonists in Older Patients With Ulcerative Colitis: Patient-Level Pooled Analysis of Data From Randomized Trials

Treatment of older patients (more than 60 years) with ulcerative colitis (UC) can be a challenge, because they might be more vulnerable to adverse events (AEs). We determined the effects of age on the safety and efficacy of anti-tumor necrosis factor (TNF) therapy in a pooled analysis of data from randomized trials. We obtained individual patient-level data from 4 trials of anti-TNF therapy for patients with UC from the Yale Open Data Access Project. Participants were assigned to groups of older age (60 years or older) and younger age (younger than 60 years). The primary outcome was difference in serious AEs (SAEs), defined as death, life-threatening event, hospitalization, and/or significant disability. Secondary outcomes were severe infections, non-severe infections, neoplasms, and achievement of clinical remission, defined by trial investigators as Mayo score ≤ 2 with no sub-score >1 at the end of induction or maintenance therapy. A random effects logistic regression model was fitted to estimate the effect of anti-TNF therapy on safety and efficacy by age, adjusting for confounders and trial-level effects. The study cohort included 2257 patients (231 60 years or older). Higher proportions of older patients receiving anti-TNF therapy had SAEs (20%) and hospitalizations (14.4%), compared with younger patients (10.2% had SAEs and 5.2% were hospitalized); there were no significant differences between groups in proportions with severe or non-severe infections. Compared with placebo, there was no significant difference in safety risks associated with anti-TNF therapy (SAEs reduced by 5.4% in older patients vs reduction of 2.4% in younger patients; hospitalizations reduced by 6.7% in older patients vs reduction of 2.5% in younger patients; severe infections reduced by 3.1% vs increase of 0.7% in younger patients). There was no significant difference in between older vs younger patients in efficacy of anti-TNF therapy in inducing remission (odds risk ratio, 1.05, 95% CI, 0.33-3.39) or in maintaining remission (odds risk ratio, 0.49; 95% CI, 0.18-1.33). In a pooled analysis of data from randomized trials, we found that older patients with UC have an increased baseline increased risk of SAEs, but no increase in risk can be attributed to anti-TNF therapy in older vs younger patients.

Drug S-oxidation and phenylalanine hydroxylase: a biomarker for neurodegenerative susceptibility in Parkinson's disease and amyotrophic lateral sclerosis.

Background The S-oxidation of S-carboxymethyl-L-cysteine has been reported previously to be a biomarker of disease susceptibility in Parkinson's disease and amyotrophic lateral sclerosis. In the present investigation, the original observations have been extended and confirmed. Methods Meta-analysis of previously published investigations into the S-oxidation polymorphism together with new subject data was evaluated. Results The incidence of the poor metaboliser phenotype (no urinary recovery of S-oxide metabolites) was found to be 3%-7% within healthy and non-neurological disease populations, whereas 38% of the Parkinson's disease subjects and 39% of the amyotrophic lateral sclerosis group were phenotyped as poor metabolisers. The consequent odds risk ratio of developing Parkinson's disease was calculated to be 33.8 [95% confidence interval (CI), 13.3-86.1] and for amyotrophic lateral sclerosis was 35.2 (95% CI, 13.0-85.1). Conclusions The possible involvement of the enzyme responsible for this S-oxidation biotransformation reaction, phenylalanine hydroxylase, should be further investigated to elucidate its potential role in the mechanism(s) of toxicity in susceptible individuals displaying these diseases. The "Janus hypothesis," possibly explaining why phenylalanine hydroxylase is a biomarker of neurodegenerative disease susceptibility, together with the general theme that this concept may apply to many other hitherto unsuspected enzyme systems, is presented.

Phenylalanine hydroxylase: A biomarker of disease susceptibility in Parkinson’s disease and Amyotrophic lateral sclerosis

The S-oxidation of S-carboxymethyl-l-cysteine has been reported previously to be a biomarker of disease susceptibility in Parkinson’s disease and Amyotrophic lateral sclerosis. In this investigation, the original observations have been confirmed with the incidence of the poor metaboliser phenotype (no urinary recovery of S-oxide metabolites) being found to be 3.9% within healthy control population. However, 38.3% of the Parkinson’s disease subjects and 39.0% of the Amyotrophic lateral sclerosis group were phenotyped as poor metabolisers. The consequent odds risk ratio of developing Parkinson’s disease was calculated to be 15.5 (95% CI 9.5–25.3) and for Amyotrophic lateral sclerosis was 15.2 (95% CI 8.8–26.5). Thus, the possible role of the enzyme responsible for the S-oxidation biotransformation reaction, phenylalanine hydroxylase, must be further investigated to elucidate the mechanism(s) of toxicity in susceptible individuals displaying these diseases. A dual role potentially explaining of the role of phenylalanine hydroxylase as a biomarker of disease susceptibility is presented together with the observation that metabolomics is a possible way forward in the identification of potential pro-toxins/toxins in those individuals phenotyped as poor metabolisers (Controls, Parkinson’s disease and Amyotrophic lateral sclerosis subjects).

Obstructive Sleep Apnea: Epidemiology and Portuguese patients profile

IntroductionObstructive Sleep Apnea (OSA) is characterized by recurrent episodes of apnea and hypopnea, secondary to collapse of the upper airways during sleep. OSA is frequently associated to cardiovascular complications. In Portugal, its magnitude is unknown. MethodsIn 2014 a cross-sectional study was performed using the Portuguese General Practitioner (GP) Sentinel Network (Rede Médicos Sentinela). Participants GP reported all OSA cases diagnosed and registered in their lists of users on the 31 December 2013.Frequency of OSA has been estimated by sex and age. OSA patients were also characterized by method of diagnosis, treatment, and underlying conditions.Association between risk factors and severe OSA (odds ratio) was calculated using a logistic regression model adjusting confounding. ResultsPrevalence of OSA on the population aged 25 years or more was 0.89% (95 CI: 0.80–1.00%); it was higher in males 1.47% (95 CI: 1.30–1.67%) and in those aged between 65 and 74 (2.35%). Most had severe OSA (48.4%). Hypertension (75.9%), obesity (74.2%) and diabetes mellitus (34.1%) were the most frequent comorbidities. Being a male (OR: 2.6; 95 CI: 1.2–5.8) and having obesity (OR: 4.0; 95 CI: 1.8–8.6) were associated with an increased risk of severe OSA. ConclusionFound frequency of OSA was lower than other countries estimates, which may be explained by differences on case definition but can also suggest underdiagnosis of this condition as reported by other authors.

English

Objective: The purpose of this study is to identify the causes of ocular trauma, determine the groups at risk and types of injuries presenting to the Eye Unit at the University Hospital of the West Indies. Method: A prospective observational study was done over a 14-month period on trauma related referrals to the ophthalmology department. A questionnaire was administered and data were collected on the patient’s age, gender, affected eye, aetiology and location of trauma, visual acuity and intraocular pressure (IOP). Statistical analysis was performed using STATA. Results: There were 84 eyes of 80 patients, of which 71.3% were males and 28.7% were females. The ages ranged from 3‐64 (mean 31.2 ± 15.1) years. The highest incidence of trauma was seen in the 18‐ 35-year age group (41.3%). Males had an odds ratio risk of 1.37. Blunt trauma occurred in 35.7% of cases and penetrating trauma in 33.3% of cases. The highest incidence of eye injury occurred at home (47.5%) followed by the workplace (25.0%), then road traffic setting (13.8%). Assault-related eye injury was seen in 17.5% of cases and 62.5% of all injuries were accidental. The rate of hospitalization was 40.5%, of which 85.3% were males while 14.7% were females. Previous trauma in the affected eye occurred in 14.3% of cases. Conclusions: Males have a high odds risk ratio of ocular trauma. The majority of eye injuries occur in the home environment. Most injuries were accidental and could be avoided with the use of eye protection or care with interpersonal and work-related activities.

Systematic review and meta-analysis of published, randomized, controlled trials comparing suture anastomosis to stapled anastomosis for ileostomy closure

The objective of this article is to systematically analyze the randomized, controlled trials comparing the effectiveness of suture anastomosis (SUA) versus stapled anastomosis (STA) in patients undergoing ileostomy closure. Randomized, controlled trials comparing the effectiveness of SUA versus STA in patients undergoing ileostomy closure were analyzed using RevMan(®), and combined outcomes were expressed as odds risk ratio (OR) and standardized mean difference (SMD). Four randomized, controlled trials that recruited 645 patients were retrieved from electronic databases. There were 327 patients in the STA group and 318 patients in the SUA group. There was significant heterogeneity among included trials. Operative time (SMD -1.02; 95 % CI -1.89, -0.15; z = 2.29; p < 0.02) was shorter following STA compared to SUA. In addition, risk of small bowel obstruction (OR 0.54; 95 % confidence interval (CI), 0.30, 0.95; z = 2.13; p < 0.03) was lower in the STA group. Risk of anastomotic leak (OR 0.87; 95 % CI 0.12, 6.33; z = 0.14; p = 0.89), surgical site infection, reoperation and readmission were similar following STA and SUA in patients undergoing ileostomy closure. Length of hospital stay was also similar between STA and SUA groups. In ileostomy closure, STA was associated with shorter operative time and lower risk of postoperative small bowel obstruction. However, STA and SUA were similar in terms of anastomotic leak, surgical site infection, readmission, reoperations and length of hospital stay.

Genome-wide Studies in Pharmacogenomics: Harnessing the Power of Extreme Phenotypes

Baldwin et al. on paclitaxel-induced sensory peripheral neuropathy [5], and Brown et al. on temozolomideassociated cytotoxicity [6] have advanced our understanding of DNA sequence variations and drug response, and several pharmaco genomic tests are on their way to clinical practice [7]. The studies on toxic drug reactions in particular have extra power compared with typical GWAS. For example, the study by Daly et al. on flucloxacillin-induced liver injury, an extreme and rare drug response phenotype, included only 51 affected individuals and 282 controls, yet it reported the unprecedented odds risk ratio of 80.6 (p = 8.7 × 10 for carriers of HLA-B*5701) [4], while typical GWAS odds risk ratios are below 2. We propose that the extreme phenotypes approach should be prioritized for genomewide pharmacogenomic studies, including those exploring genomic biomarkers for treatment efficacy as an alternative to enrolling very large random patient cohorts. This is based on both the likelihood of an enrichment for genomic signal due to the ‘Mendelian’ nature of the pheno type, the favorable study costs and reduced ‘noise’ arising from inaccurate pheno typing. Taken together, it seems far more effective to compare genome-wide data between ‘excellent drug responders’ versus nonresponders, compared with analyzing such data from huge patient cohorts representing a large spectrum of intermediate responders. The superior power of the extreme phenotype approach is exemplified by the recent study of Edmond et al., who identified DCTN4 as a modifier of chronic infection in cystic fibrosis among 91 individuals whose exomes were sequenced [8]. As a further example, expression levels of CHL1 were recently reported as Four years ago this journal featured a theme issue on genome-wide association studies (GWAS) in pharmacogenomics. In our accompanying editorial we noted that “relatively few GWAS on drug response were so far published compared with the large numbers of disease risk GWAS” and called upon the pharmacogenomics research community to apply this powerful, hypothesis-free research approach for improving knowledge on drug safety and efficacy [1]. Our call seems to have been timely, as the past few years have witnessed an increase in pharmacogenomics-oriented genome-wide studies. Among PubMed-listed pharmacogenomics-related manuscripts, the fraction of those mentioning both ‘pharmacogenomics’ and ‘genome-wide’ as keywords have risen fourfold over the past few years, from 2.1% in 2006 to nearly 9% of total manuscripts published between 2009 and 2012 (Table 1). However, as in past years, only a tiny fraction (under 2%) of published genome-wide studies (in all areas) are concerned with pharmacogenomics (Table 1), a disappointingly low figure considering the huge societal burden of adverse drug events and ineffective therapeutics [2].

Relationships of occupational and non-occupational physical activity to abdominal obesity

Physically active occupations may protect against the risk of abdominal obesity. This study assessed the interaction between non-occupational physical activity (NOA) (leisure-time, transport and domestic activity) and occupational activity (OA) in relation to abdominal obesity. A total of 3539 adults over the age of 20, with no work limitations, employed in one of the 17 occupations classified as low OA (LOA) or high OA (HOA) were identified in the 1999-2004 National Health and Nutrition Examination Survey. Waist circumference (WC) was used to categorize individuals into either non-obese or abdominally obese (WC>88 cm in women and >102 cm in men) categories. NOA was divided into three categories based upon physical activity guidelines: (1) no NOA; (2) insufficient NOA; and (3) sufficient NOA. Logistic regression was used to examine possible associations between NOA, OA and abdominal obesity. In those who are sedentary outside of work, a high-activity occupation reduces the odds risk ratio of being categorized with abdominal obesity to 0.37 in comparison with those who work in low-activity occupations. For people working in low-activity occupations, there was a clear association with activity outside of work and the odds risk ratio of being categorized with abdominal obesity. In these adults, a reduced odds ratio was found only among those who met the physical activity guidelines through NOA (odds ratio=0.55; 95% confidence interval (CI)=0.40-0.75). HOA is associated with a reduced risk of abdominal obesity. Thus, it is important to include OA in studies seeking to understand the association between physical activity and abdominal adiposity.

Outcomes in elderly patients with acute coronary syndromes randomized to enoxaparin vs. unfractionated heparin: results from the SYNERGY trial

Elderly patients are at high risk from non-ST-segment elevation acute coronary syndromes (NSTE ACS) as well as from treatment-related complications. Age-associated changes in physiology may alter the risk and benefit expected from therapy. The SYNERGY database was used to study the influence of age on treatment outcomes with enoxaparin vs. unfractionated heparin (UFH) in patients with high-risk NSTE ACS. Age was analysed as a continuous and categorical variable (<65, 65-74, and >or=75 years, and <75 and >or=75 years) for descriptive purposes. Logistic regression was used to adjust the outcomes of 30-day death, death or myocardial infarction (MI), and major bleeding for baseline characteristics. Odds ratios compared outcomes by age and by treatment within age groups. Model interaction terms were used to test for statistically different outcomes by treatment and age. Overall, 9977 randomized patients had age information, of whom 25.5% (2540) were >or=75 years of age. Elderly patients (>or=75 years) had more cardiovascular risk factors, prior cardiac disease, and higher acuity at presentation. After adjustment, advanced age (per 10 years) was associated with 30-day death or MI [risk odds ratios (ROR): 1.14, P = 0.002], 30-day death (ROR: 1.54, P < 0.0001), and 1-year death (ROR: 1.47, P < 0.0001), as well with TIMI major bleeding (ROR: 1.21, P = 0.001), GUSTO severe bleeding (ROR: 1.20, P = 0.047), and transfusion (ROR: 1.04, P = 0.324). Although there was a higher rate of GUSTO severe bleeding noted with enoxaparin in elderly patients, the overall relationships between treatment (UFH or enoxaparin) and outcomes did not vary significantly as a function of the patient's age. Although higher rates of adverse events are seen in the oldest subgroup (age >or=75 years) treated with enoxaparin, statistical comparisons confirm similar efficacy and safety of enoxaparin and UFH across age subgroups as was demonstrated overall in SYNERGY.

Knee complaints and consequences on work status; a 10-year follow-up survey among floor layers and graphic designers

BackgroundThe purpose of the study was to examine if knee complaints among floor layers predict exclusion from the trade.MethodsIn 1994/95 self-reported data were obtained from a cohort of floor layers and graphic designers with and without knee straining work activities, respectively. At follow-up in 2005 the questionnaire survey was repeated. The study population consisted of 81 floor layers and 173 graphic designers who were presently working in their trades at baseline (1995). All participants were men aged 36–70 years in 2005.We computed the risk of losing gainful employment in the trade according to occurrence of knee complaints at baseline, using Cox proportional hazard regression adjusted for a number of potential confounding variables. Moreover, the crude and adjusted odds risk ratio for knee complaints according to status of employment in the trade were computed, using graphic designers as reference.ResultsA positive but non-significant association between knee complaints lasting more than 30 days the past 12 months and exclusion from the trade was found among floor layers (Hazard Ratio = 1.4, 95% CI = 0.6–3.5).The frequency of self-reported knee complaints was lower among floor layers presently at work in the trade in year 2005 (26.3%) compared with baseline in 1995 (41.1%), while the opposite tendency was seen among graphic designers (20.7% vs. 10.7%).ConclusionThe study suggests that knee complaints are a risk factor for premature exclusion from a knee demanding trade. However, low power of the study precludes strong conclusions. The study also indicates a healthy worker effect among floor layers and a survivor effect among graphic designers.

The Metabolic Syndrome

The abundance of names identifying the Metabolic Syndrome (MetS) is congruent with the competing criteria for defining the syndrome. To date, there is no consensus of the best definition used to diagnose the MetS. PURPOSE: To examine the relationships various definitions have on MetS prevalence and risk estimates among a national sample of adults. METHODS: The sample for this study-included adults, 20 years and older, (N=3745) who completed the mobile examination center (MEC) examination in the 1999–2002 National Health and Nutrition Examination Survey (NHANES). Prevalence estimates were determined based on the requisites for the 5 most commonly used definitions for diagnosing the MetS. SUDAAN statistical software was used to estimate age-adjusted prevalence and odds risk ratios. RESULTS: The overall age-adjusted MetS prevalence ranged from a high of 42.3% (ACE/AACE), to a low of 22.3% (WHO). Consistently across MetS definitions, males, people in the seventh decade of life (60–69 years of age), Mexican-Americans, those without a high school education, and those living in poverty were found to have the greatest prevalence. Corresponding to prevalence estimates, females were 23% to 30% less likely to be diagnosed with the MetS. People in the seventh decade of life, Mexican-Americans, those with less than a high school education and those living in poverty were found to have the greatest risk for being diagnosed with the MetS. CONCLUSION: MetS prevalence and risk estimates within populations are highly dependent on the criteria and definition used. This has implications for future physical activity epidemiology research in the hypothesized dose-response relationships with the MetS.

Metabolic Syndrome and its Relationship to Total Physical Activity

In the past, the examination of the relationship between physical activity (PA) and the metabolic syndrome (MetS) has been restricted to leisure-time physical activity. The 1999–2002 National Health and Nutrition Examination Survey (NHANES IV) currently assesses PA across all domains (leisure-time, transportation, and domestic), therefore providing a more precise measure of PA. PURPOSE: To explore the relationship between total PA (leisure-time, transportation, and domestic) and the MetS among a national sample of adults. METHODS: The sample for this study-included adults, 20 years and older, (N=3742) who completed the mobile examination center (MEC) examination in NHANES IV. Respondents were classified as having or not having the MetS based on the National Cholesterol Education Program-Adult Treatment Panel III, with a threshold of 3 out of 5 criteria being met. Each subject completed a PA interview that assessed the intensity, frequency, and duration for PA in all domains. PA was expressed as weekly MET-minutes and captured PA from the leisure-time, transportation, and domestic domains. SUDAAN statistical software was used to estimate age-adjusted prevalence of MetS and odds risk ratios. RESULTS: The national age-adjusted prevalence for the MetS was 26.9% (SE=0.8). Prevalence of the MetS among adults meeting the ACSM/CDC recommendation for PA was 22.3% (met recommendation), 28.0% (some, but insufficient PA), and 35.7% (physically inactive), demonstrating a potential dose-response relationship. Compared to those in the least active quintile, there was a 38% (3rd quintile), 46% (4th quintile), and 53% (5th quintile) reduced risk for meeting the MetS criteria. CONCLUSION: The prevalence of the MetS in the NHANES IV (26.9%) has increased slightly since the NHANES III (23.7%). However, lower prevalence and risk for the MetS was found to be associated beginning with moderate levels of total PA as expressed by weekly MET-minutes.

Complex Disease: A new vision for age-related macular degeneration

Complex Disease: A new vision for age-related macular degeneration

The siesta and mortality in the elderly: effect of rest without sleep and daytime sleep duration.

To examine the effects of daytime rest without sleep and duration of the siesta on mortality. Longitudinal observation. Population sample of 442 community-dwelling 70-year-old subjects examined both at home and in a geriatric hospital. N/A. Overall mortality for those who neither rested nor slept was 9.3%, for those who rested without sleep 10.9%, and for those who slept 19%, p<0.02. Males had higher mortality (19%) than females (10%), p<0.006. Rest without sleep had no effect on mortality: in males, 13%, 21%, 18% for no rest, rest of less than one hour, or more than one hour with respective 8%, 6% and 4% in females. However, daytime sleep in males of more than one hour had 28.2% mortality, whereas sleep of one hour or less had 13.6% mortality, p=0.02. In females mortality rate was not different by sleep duration: 16% and 13.6% for those who slept for one hour or less, or more than one hour, respectively. In a multivariate analysis in females, a siesta of one hour or less was associated with risk odds ratio (ROR) of 4.67 and 95% confidence interval (CI) 1.22-17.80 and of one to two hours, ROR was 5.57 and 95% CI 1.05-29.49. For males, siesta of less than one hour was not associated with excess risk, ROR 0.9 and 95% CI 0.39-2.38; a siesta of one to two hours with ROR of 2.61 and 95% CI 1.01-6.80; and two hours or more ROR 13.6 and 95% CI 0.98-2.10. Rest without sleep is not associated with excess risk of mortality. However, siesta of one to two hours is associated with increased mortality in males whereas, in women, a siesta of less than one hours confers the excess risk.

Developmental outcomes of children with hearing loss born in Colorado hospitals with and without universal newborn hearing screening programs

The developmental outcomes of children born in hospitals with universal newborn hearing screening programs were compared with children born in hospitals without universal newborn hearing screening programs. Eight-four percent of children born in screening hospitals were early-identified with hearing loss prior to 6 months of age as compared to 8% of the children in the non-screen group. The participants in the screen group had an average language quotient of 82 while the participants in the non-screen group had an average language quotient of 62. Children in the screen group had better receptive and expressive language quotients, more different consonants in the spontaneous phonetic repertoire, better speech intelligibility, and larger expressive vocabulary inventories. Odds risk ratio estimates indicate that 80% of the children with cognitive quotients 80 or greater or four out of five children had language quotients within the normal range, 80 or greater, when they were in the screen group.

A review of xenobiotic metabolism enzymes in Parkinson's disease and motor neuron disease.

The role of xenobiotic metabolising enzymes (XMEs) in disease aetiology has been under investigation by numerous researchers around the world for the last two decades. The association of a number of defects in both phase I and phase II reactions with Parkinson's disease (PD) and motor neuron disease (MND) have been extensively studied. This review of the work of the group based initially at the University of Birmingham into the functional genomics of XMEs and neurodegenerative diseases has indicated that: 1. Sub-groups of patients with PD and MND can be identified with problems in xenobiotic metabolism by in vivo or in vitro methods. 2. 38-39% of the patients with MND/PD have a defect in the S-oxidation of the mucoactive drug, carbocysteine, by an unknown cytosolic oxidase(s). The odds risk ratio for the association of this defect with these diseases was calculated to be 10.21 for MND and 10.50 for PD. 3. Patients with PD appear to have an altered substrate specificity for monoamine oxidase B substrates in an in vitro platelet assay. 4. Patients with MND have an increased capacity to S-methylate aliphatic sulphydryl compounds in an in vivo challenge as well as an in vitro erythrocyte thiol methyltransferase assay. The results of over a decade of investigations into both PD and MND indicate that these are diseases with mutifactorial origins that encompass both genetic predisposition and environmental insult.

Epidemiology and prevalence of onychomycosis in HIV-positive individuals.

Patients who are human immunodeficiency virus (HIV) positive are predisposed to the development of infections including tinea pedis and onychomycosis. While smaller studies have been reported, there has been no large study evaluating the prevalence of onychomycosis in HIV-positive individuals, or comparing the development of onychomycosis in a typical temperate area with that in a typical tropical area. HIV-positive individuals were evaluated at five clinics: four in Ontario, Canada and one in Sao Paulo, Brazil. The subjects were asked questions to determine the epidemiology of onychomycosis in HIV-positive individuals. The feet were examined and nail material was obtained for mycologic examination to determine the causative organism of onychomycosis. A total of 500 subjects were examined (415 men and 85 women; age (mean +/- SE), 39 +/- 0.4 years; 400 Canadian, 100 Brazilian). The racial origins of the Canadian patients were: Caucasian, 83.8%; Asian, 4.3%; African-American, 8.1%; Hispanic, 3.3%; American Indian, 0.3%. The Brazilian origins were: Caucasian, 68.7%; African, 18.1%; mixed race, 13.3%. Abnormal appearing nails and mycologic evidence of onychomycosis were present in 200 (40.0%) and 116 (23.2%), respectively, of 500 subjects. The prevalence of onychomycosis in the Canadian and Brazilian samples was 24.0% (96 of 400) and 20.0% (20 of 100), respectively. The projected prevalence of onychomycosis in HIV-positive individuals in Canada was 19.9% (95% CI: 16.0-23.9%) after taking into account the age and sex distribution of HIV-positive individuals in the population. When nails appeared clinically abnormal, the prevalence of onychomycosis was 50.5% (Canada, 51.3%; Brazil, 45.5%). For comparison, published data indicate that the prevalence of onychomycosis in immunocompetent individuals living in Canada is 6.9%. The clinical presentation of onychomycosis for the whole sample (n=500) was: distal and lateral subungual onychomycosis (DLSO), 20.0%; white superficial onychomycosis (WSO), 3.6%; proximal subungual onychomycosis (PSO), 1.8% (Canadian and Brazilian samples: DLSO 21.2% vs. 15.0%, WSO 3.3% vs. 5.0%, and PSO 1.5% vs. 3.0%). The distribution of the causative fungal organisms was: dermatophytes: Candida species: nondermatophyte molds, 73:2:2 (Canadian and Brazilian samples: dermatophytes 95.5% vs. 90.9%, Candida species 3.0% vs. 0%, and nondermatophyte molds 1.5% vs. 9.0%). The use of protease inhibitors, reverse transcriptase inhibitors, or oral antifungal agents did not make a significant difference in the prevalence of onychomycosis for both the Canadian and Brazilian groups. Patients with onychomycosis were aware of their abnormal appearing nails (chi2(1)=69.7, P<0.001), embarrassed by the appearance of their nails (chi2(1)=29.7, P<0.001), and took measures to hide their nails from other individuals. A higher proportion of individuals with onychomycosis experienced discomfort compared with those without the disease (chi2(1)=9.0, P=0.003). Also, individuals who experienced pain in the nail unit were more likely to have onychomycosis (risk odds ratio (ROR), 2.2; 95% CI: 1.0-4.7, P=0.05). The prevalence of onychomycosis in HIV-positive individuals in the sample of 500 patients was 23.2%. In the Canadian (n=400) and Brazilian (n=100) samples, the corresponding figures were 24% and 20%, respectively, with the predominant causative organisms being dermatophytes. The projected prevalence of onychomycosis in HIV-positive Canadians is 19.9%. Predisposing factors include a CD4 count of approximately 370, a positive family history of onychomycosis, a history of tinea pedis, and walking barefoot around pools. Onychomycosis can be symptomatic, a source of embarrassment, and a potential cause of morbidity.

Use of antibiotics during pregnancy

Objective: To describe the occurrence and distribution of antibiotic treatments, in addition their indications in control pregnant women in the population-based large dataset of the Hungarian Case–Control Surveillance of Congenital Abnormalities, 1980–1996. Results: Of 38 151 control pregnant women who delivered later newborn infants without congenital abnormality, 6554 (17.2%) were treated by antibiotics. Most women (14.5%) had penicillin, while 1.2% and 0.7% of pregnant women were treated by cephalosporins and tetracyclines, respectively. More than 100 pregnant women used the following antibiotics: ampicillin (6.9%), penamecillin (5.9%), cefalexin (1.0%), phenoxymethylpenicillin (0.6%), oxytetracycline (0.5%), erythromycin (0.45%), benzylpenicillin-procain (0.4%) and benzylpenicillin+benzylpenicillin-procain (0.3%). Different antibiotics had different indications for treatment. The mean birth weight was significantly lower in the treated group compared to the untreated group. Practical implications: Different antibiotics have different chemical structures and indications for treatment. Therefore it is not appropriate to evaluate their teratogenic potential of combined antibiotic groups. There may be many interactions between underlying maternal diseases, other drug uses, further confounding factors and antibiotics studied, thus adequate controls are needed to estimate the adjusted teratogenic odds–risk ratios. European countries have different spectrum of antibiotic use. It would be necessary to know these baseline data of different populations. The anxiety and fear created by the notion that nearly all drugs cause congenital abnormalities may be more harmful than some proven human teratogenic drugs themselves. Thus a better risk–benefit estimation for antibiotic uses during pregnancy is an urgent and important task.

Prenatal Factors Influencing Survival of Infants Born at 24-26 weeks Gestation † 1105

In the past decade there have been more infants of extremely low gestational age (ELGA) treated in NICUs and a significant increase in their survival. In general, neonatal survival reports are analyzed and compared based on neonatal factors, like birth weight, and scores of disease severity. The impact of prenatal risk factors in mortality for infants born at this ELGA has not been reported. To identify prenatal factors that could affect their survival, we reviewed the data of all inborn infants delivered in the last five years (1992-96) whose G.A. was 24-26 weeks defined by best obstetrical estimate. Prenatal factors analyzed included, among others, maternal age, race, parity, prenatal care, antenatal steroids, fetal sex and drug abuse. The main outcome variable was infant mortality before discharge. The data was analyzed by multiple regression analysis and odds-risk ratios were calculated. There were a total of 130 live born infants from 129 mothers; survival rate to discharge was 73%. Among the mothers, 6% were ≤19 and 71% were 20-35 years of age, 51% were Black (B), 30% Caucasian (C), 16% Hispanic (H), 21% were nulliparous (P-O), 97% received prenatal care, and 65% received antenatal steroids. Gestational age was 24 wks in 31%, 25 wks in 25% and 26 wks in 44%; 62% were males and 5% were exposed to street drugs. The mortality rates for some of the individual prenatal factors is shown in the table below. In this population of mothers with adequate prenatal care delivering ELGA infants, maternal race, hypertension, duration of ROM, and fetal sex did not independently increase risk of mortality. Nulliparity and lack of antenatal steroids showed an independent tendency to decreased survival, but without statistical significance. Maternal age ≤19 and 24 wks GA were the best independent prenatal predictors of mortality. When both occur together, the risk for mortality increases between 2.5 and >10 fold when compared to other GA and maternal ages. We conclude that at this lowest extreme of viability, infant survival is markedly different according to prenatal risk factors. This needs to be incorporated in any clinical trial or outcomes research comparison.

An evaluation of clinical predictors to determine need for rectal temperature measurement in the emergency department

A cross-sectional study was conducted in an urban emergency department to determine if predictive variables existed that would identify a patient who would be afebrile by oral temperature measurement and febrile by rectal temperature measurement. This study included 366 patients. Five variables studied achieved statistical significance by univariant analysis: mouth breathing ( P = .002), respiratory rate ( P = .001), supplemental oxygen ( P = .009), pulse ( P = .0001), and supplemental oxygen via mask ( P = .01). Placing these variables in a logistic regression model left two variables that significantly explained the variance of the model: pulse (odds-risk ratio, 1.032/increase in pulse of 1 from 0; 95% confidence interval, 1.020 to 1.039) and mouth breathing (odds-risk ratio, 2.113; 95% confidence interval, 1.41 to 3.43). There was poor linear correlation between oral and rectal temperatures ( r = 0.2). If a patient has an unexplained tachycardia and/or is breathing by mouth and is afebrile orally, a rectal temperature measurement should be obtained to determine if fever exists. The results of this study suggest that good linear correlation does not exist between oral and rectal temperature measurements.