Prospective Multicenter Case-control Study Research Articles

Microbial aetiology of healthcare associated pneumonia in Spain: a prospective, multicentre, case–control study

IntroductionHealthcare-associated pneumonia (HCAP) is actually considered a subgroup of hospital-acquired pneumonia due to the reported high risk of multidrug-resistant pathogens in the USA. Therefore, current American Thoracic Society/Infectious Diseases Society...

A prospective multicenter clinical trial of medical and surgical treatment for chronic rhinosinusitis

To demonstrate the clinical outcomes of maximal medical therapy(MMT) and functional endoscopic sinus surgery+ maximal medical therapy (FESS+MMT) for moderate to severe chronic rhinosinusitis without nasal polyps (CRSsNP) in China, to provide clinical evidence for treatment recommendation. A prospective multicenter case control study consisting of 90 strictly selected CRSsNP patients were carried out by ENT Hospital of SUN Yet-sen university and 7 other university affiliated hospitals across China from March 2011 to October 2012. All patients were selected to MMT group or FESS+MMT group followed by 3 months treatment and 6 months follow up. Treatment efficacy evaluation indicators included improvement of visual analogue scale (VAS) score, quality of life, CT score and post-operative nasal endoscopic evaluations. SPSS16.0 software was used to analyze the data. All patients enrolled complied with moderate to severe CRSsNP evaluation criteria. There were no significant differences found in the baseline data between two groups (P > 0.05). (1) At the 3 time points (pre-treatment, 3 months and 6 mongths after treatment) , VAS overall symptom score in MMT group were 6.52 ± 2.61, 2.66 ± 2.10, 2.40 ± 1.56, significant differences were found among them (t value were 2.083 and 2.295, both P < 0.05); in FESS+MMT group the values were 6.99 ± 2.70, 0.95 ± 0.84, 0.60 ± 0.81, significant differences were found among them (t value were 3.582 and 5.196, both P < 0.05); SNOT-20 score in MMT group were 38.61 ± 17.36, 18.59 ± 14.04, 18.40 ± 8.91, significant differences were found among them (t value were 2.737 and 2.657, both P < 0.05); in FESS+MMT group the values were 38.21 ± 19.61, 5.94 ± 5.01, 2.65 ± 2.31, significant differences were found among them (t value were 3.247, 3.319, both P < 0.05). (2) FESS+MMT group relative to the MMT group in VAS overall symptom score and quality of life improvements appeared earlier and were more pronounced. (3) Overall treatment efficacy showed that in MMT group: complete control 14 cases (30.4%), partially control 31 cases (67.4%), uncontrolled 1 cases (2.2%); In FESS+MMT group: complete control 17 cases (38.6%), partially control 26 cases (59.1%), uncontrolled 1 cases (2.3%). (4) Patients' satisfaction survey showed that the number of the patients who were very satisfied with the efficacy in the FESS+MMT group were 2 times higher than the MMT group. (1) For moderate to severe CRSsNP, both MMT and FESS+MMT treatment can effectively control the overall symptoms and classified symptoms, reduce CT scores and significantly improve the quality of life, the ineffective rate is less than 5%. (2) FESS+MMT group in terms of improving symptoms and the onset time are better than MMT group, especially in improving the stuffy nose, head and face fullness, and mental and physical symptoms are better than MMT group. (3) FESS+MMT group showed better results in patient satisfaction survey compared to the MMT group. Therefore for moderate to severe CRSsNP patients, FESS+MMT therapy could be recommended as the preferred treatment.

Nevus anemicus in neurofibromatosis type 1: A potential new diagnostic criterion

Children with multiple café-au-lait macules (CALMs) may be followed for years before a second National Institutes of Health clinical criterion of neurofibromatosis type 1 (NF1) develops to confirm the diagnosis. We sought to assess the prevalence of nevus anemicus (NA) in NF1 and its association with neuro-ophthalmologic complications. This was a prospective multicenter case-control study of 210 consecutive patients with multiple CALMs. Patients with NF1 were matched for age, sex, and center with control subjects. We documented the number, location, and morphologic appearance of NA; dermatologic features of NF1; magnetic resonance imaging results; and family history. In all, 77 (51%) patients with NF1 had NA compared with 6 (2%) control subjects. NA was not detected in 26 patients with other genodermatoses associated with CALMs. Patients with NF1 and NA were younger than those without NA (median age: 17 years) (P = .002). NA was mostly localized to the upper anterior aspect of the chest. NA was not significantly linked with other clinical manifestations of NF1, including optic glioma and unidentified bright objects. A potential referral bias associated with tertiary care centers is a limitation. NA appears to have a high prevalence and specificity in NF1 and might serve as a marker for NF1 in children with multiple CALMs.

PREDICTORS OF POSTPARTUM RELAPSES IN WOMEN WITH MULTIPLE SCLEROSIS: RESULTS FROM THE MSBASE REGISTRY

BackgroundSeveral studies have shown that pregnancy reduces relapse rate in Multiple Sclerosis (MS), followed by an increased relapse rate in the early postpartum period. We re-examined the effect of pregnancy...

Myeloperoxidase Is an Early Biomarker of Inflammation and Cardiovascular Risk in Prepubertal Obese Children

OBJECTIVEObesity is associated with a state of chronic low-grade inflammation. Myeloperoxidase (MPO) plays an important role in the initiation and progression of acute and chronic inflammatory diseases, such as cardiovascular disease (CVD). The objectives of the current study were to evaluate plasma MPO levels in prepubertal obese children and to determine whether MPO could be an early biomarker of inflammation and CVD risk.RESEARCH DESIGN AND METHODSIn a prospective multicenter case-control study paired by age and sex of 446 Caucasian prepubertal children ages 6–12 years, 223 normal-weight and 223 obese children were recruited. Blood pressure, waist circumference, weight, and height were measured. In addition to MPO, glucose, insulin, metabolic lipid parameters, oxidized low-density lipoproteins, adiponectin, leptin, resistin, C-reactive protein (CRP), interleukin 6, tumor necrosis factor α, matrix metalloproteinase-9 (MMP-9), and plasminogen activator inhibitor 1 were determined.RESULTSWe found that MPO was elevated in prepubertal obese children and that this enzyme was associated with such proinflammatory and cardiovascular risk biomarkers as CRP, MMP-9, and resistin. Insulin resistance calculated by the homeostatic assessment model was the best predictor of MPO.CONCLUSIONSMPO is an early biomarker of inflammation associated with CVD risk in obese children at the prepubertal age.

Burden of Risk Alleles for Hypertension Increases Risk of Intracerebral Hemorrhage

Genetic variation influences risk of intracerebral hemorrhage (ICH). Hypertension (HTN) is a potent risk factor for ICH and several common genetic variants (single nucleotide polymorphisms [SNPs]) associated with blood pressure levels have been identified. We sought to determine whether the cumulative burden of blood pressure-related SNPs is associated with risk of ICH and pre-ICH diagnosis of HTN. We conducted a prospective multicenter case-control study in 2272 subjects of European ancestry (1025 cases and 1247 control subjects). Thirty-nine SNPs reported to be associated with blood pressure levels were identified from the National Human Genome Research Institute genomewide association study catalog. Single-SNP association analyses were performed for the outcomes ICH and pre-ICH HTN. Subsequently, weighted and unweighted genetic risk scores were constructed using these SNPs and entered as the independent variable in logistic regression models with ICH and pre-ICH HTN as the dependent variables. No single SNP was associated with either ICH or pre-ICH HTN. The blood pressure-based unweighted genetic risk score was associated with risk of ICH (OR, 1.11; 95% CI, 1.02-1.21; P=0.01) and the subset of ICH in deep regions (OR, 1.18; 95% CI, 1.07-1.30; P=0.001), but not with the subset of lobar ICH. The score was associated with a history of HTN among control subjects (OR, 1.17; 95% CI, 1.04-1.31; P=0.009) and ICH cases (OR, 1.15; 95% CI, 1.01-1.31; P=0.04). Similar results were obtained when using a weighted score. Increasing numbers of high blood pressure-related alleles are associated with increased risk of deep ICH as well as with clinically identified HTN.

2236 SERUM CALCIUM AS A PROTECTIVE MARKER AGAINST PROSTATE CANCER:

You have accessJournal of UrologyProstate Cancer: Markers II1 Apr 20122236 SERUM CALCIUM AS A PROTECTIVE MARKER AGAINST PROSTATE CANCER: Gholamreza Pourmand, MD Mostafa Hosseini, MD Sepehr Salem, MD Farzad Allameh, MD Mohammadreza Nikoobakht, MD Abdolrasoul Mehrsai, MD Sanaz Dehghani, andMD Fariba Heydari Gholamreza PourmandGholamreza Pourmand Tehran , Iran More articles by this author , Mostafa HosseiniMostafa Hosseini Tehran , Iran More articles by this author , Sepehr SalemSepehr Salem Tehran , Iran More articles by this author , Farzad AllamehFarzad Allameh Tehran , Iran More articles by this author , Mohammadreza NikoobakhtMohammadreza Nikoobakht Tehran , Iran More articles by this author , Abdolrasoul MehrsaiAbdolrasoul Mehrsai Tehran , Iran More articles by this author , Sanaz DehghaniSanaz Dehghani Tehran , Iran More articles by this author , and Fariba HeydariFariba Heydari Tehran , Iran More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.02.2412AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES There are conflicting reports over the dietary intake of calcium, circulating Vitamin D and subsequently serum calcium level with prostate carcinogenesis and yet no consistent evidence of an association between these factors and risk of prostate cancer (PC) has been provided, particularly in Asian population with different lifestyle and dietary habits. This study sought to further evaluate the possible effects of serum calcium level on PC risk in a different geographic setting, with special regard to age, body mass index (BMI) and sex steroid hormones. METHODS Using data from a prospective hospital-based multi-center case-control study, serum calcium concentration as well as thorough demographic and medical characteristics were determined in 194 cases with newly diagnosed, clinicopathologically confirmed PC and 317 controls, without any malignant disease, admitted to the same network of hospitals. Serum calcium levels were categorized into tertiles. Multivariate logistic regression model was used to estimate odds ratios (OR) and corresponding 95% confidence intervals (CI) after adjustment for major potential confounders, including age, BMI, smoking, alcohol, education, occupation, marital status, family history of PC and sex hormones level. RESULTS The mean serum calcium level (±SD) in case and control groups was 9.22 (±0.46) mg/dl and 9.48 (±0.51) mg/dl, respectively; this difference was proved to be statistically significant (p < 0.001). After adjustment for mentioned confounders, a significant trend of decreasing risk was found for serum calcium concentration (OR: 0.27, 95% CI: 0.12-0.59, comparing the highest with the lowest tertile). An increase of 1 mg/dl in serum calcium level was associated with a significant decrease in risk of PC (OR: 0.52; 95% CI: 0.34-0.76). Moreover, we found no correlation between the serum calcium concentration and age, BMI, prostate specific antigen, total testosterone, bioavailable testosterone and/or estradiol level. CONCLUSIONS Our findings support the hypothesis that serum calcium could be considered as a protective biomarker against PC development. Furthermore, these data do not suggest sex steroid hormones being an intermediate in the biological causal pathway between calcium concentration and PC risk. © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 187Issue 4SApril 2012Page: e902 Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.MetricsAuthor Information Gholamreza Pourmand Tehran , Iran More articles by this author Mostafa Hosseini Tehran , Iran More articles by this author Sepehr Salem Tehran , Iran More articles by this author Farzad Allameh Tehran , Iran More articles by this author Mohammadreza Nikoobakht Tehran , Iran More articles by this author Abdolrasoul Mehrsai Tehran , Iran More articles by this author Sanaz Dehghani Tehran , Iran More articles by this author Fariba Heydari Tehran , Iran More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

A Multicenter Case-Control Prospective Study to Assess the Risk of Immune Thrombocytopenia (ITP) Associated with Vaccines in Adults Using the PGRx-ITP Registry

Abstract 1169 Background and objectivesImmune thrombocytopenia (ITP) is thought to result from an autoimmune mechanism, and some case-reports have suggested that immunizations could be involved and trigger the autoimmune process. This prospective multicenter case-control study investigated for the first time associations between ITP and vaccination in adults, particularly between ITP and influenza vaccinations. MethodsOver a three year period, a network of 15 physicians from hematology and internal medicine referral centers across France recruited newly diagnosed cases of primary ITP in patients aged over 15 years fulfilling the ITP standardized criteria of the American Society of Hematology. Recruiting physicians completed standardized forms for each patient and every patient underwent a standardized 1 hour-interview focused on previous medications and vaccinations in the last 12 months. Incident ITP cases were compared to sex and age-matched controls selected and recruited from general practice settings, also from the same geographically areas of France. The method of referent recruitment has been described elsewhere (Grimaldi-Bensouda et al. 2010 Pharmacoepidemiol Drug Saf 2010;19(6):591–5). Controls were also interviewed in the same standardized way as cases. Cases and control were compared in respect of various descriptive factors and potential risk factors for ITP. Written or other confirmation of vaccinations was sought from both the patient and his/her physician. The time window defining exposure to vaccines was 12 months before the index date. In secondary analysis, the most prevalent vaccines in adults were analyzed. ResultsTwo hundred and twenty four cases fulfilling the inclusion criteria and 4412 were included in the study. Seventy eight of the 224 cases (34.8%) and 1566 of 4412 controls (35.5%) received a vaccination within this time window [adjusted odds ratio 0.97, 95% confidence interval 0.70–1.33]. Twenty percent of the cases and 26% of controls received an influenza vaccine [adjusted odds ratio 0.66, 95% confidence interval 0.45–0.98]. Other prevalent vaccines in adult are currently under study. ConclusionsThis systematic case-control design is well-suited to study rare disorders such as ITP and few such studies have been conducted. Another advantage was the minimization of recall bias because questions about vaccinations were included in a standardized interview focusing on exposure to all medications. When all vaccines were considered, we found no association between vaccination and the incidence of ITP in either crude or adjusted analyses. Moreover, cases were less likely than controls to have been vaccinated against influenza in the 12 months before the index date. Disclosures:Grimaldi-Bensouda:LA-SER: Employment; INSERM: I was the recipient of a research fellowship from the INSERM (French National Institute for Health and Medical Research) at the time of the study. Leighton:LA-SER Europe Ltd: Employment. Aubrun:LA-SER Europe Ltd: Employment. Abenhaim:LA-SER Europe Ltd: I'm a stock owner and chairman of LA-SER, the company conducting the study.

Prothrombotic Coagulation Factors (PTCF) in Symptomatic Neonatal Cerebral Infarction (SNCI). What is their Role?

Background: PtCFs have been associated with SNCI, but their relative risks is still unknown.Objective: To examine the extent to which single and combined PtCF influence the onset of SNCI.Methods: Prospective multicenter case-control study. Factor V (FV) G1691A mutation; Prothrombin (PT) G20210A variant; MTHFR T677T genotype; Antithrombin III (AT); Protein C; Protein S; Lipoprotein (Lp-a); Homocystein and anticardiolipin antibodies were investigated in 29 infant-mother pairs with SNCI and in 28 infant-mother control pairs.Results: Eight of 29 patients (28%) had at least 1 PtCF compared with 9/28(33%) controls. PtCF were found in 17(58%) mothers of infants with infarction and in 9(36%) of mothers of healthy infants (OR 2,1, 95%CI 0,7-6,4). At least 2 factors were found in 2 neonates; one SNIC patient and one healthy control. Two mothers of a SNIC patient and a control, respectively, had at least 2 factors. Table Table Full size table Conclusion: Our data indicate that PtCF do not appear to play a major role in SNCI.

A case‐control study assessing oral‐health‐related quality of life after immediately loaded single implants in healed alveolar ridges or extraction sockets

Tooth loss reduces oral-health-related quality of life (OHRQoL) as assessed with the 14-item Oral Health Impact Profile questionnaire (OHIP-14). This prospective multicenter case-control study sought to (i) establish OHRQoL in patients requiring a single implant in the anterior maxilla and to (ii) compare these changes following implant placement and immediate provisionalization in extraction sockets with healed alveolar ridges up to 1 year. Ninety-six patients were enrolled in the study with 102 single implants (OsseoSpeed AstraTech) provisionalized immediately after placement in sockets or after placement in healed ridges. A final crown was cemented after 12 weeks. OHIP-14 was registered before surgery (baseline), after 1 (provisional crown), 6 and 12 months (final crown). Repeated measures ANOVA was performed for the seven conceptual OHIP Domains, the treatment group (extraction site socket vs. healed alveolar ridge) and time as within subjects variables. Two implants failed, 1/48 (2.1%) in the extraction group (n=46 patients) and 1/54 (1.8%) in the healed ridge group (n=50 patients). From 82 patients (87.5%), OHIP-14 was available at all time points. The overall OHIP-14 based on the mean of the seven domains increases between baseline and 6 months and remained stable afterward for the total study group and both treatment groups. Comparison between extraction and healed groups revealed no significant difference at baseline but the healed group showed a significantly higher improvement for functional limitation, physical disability, physical pain and psychological discomfort (P<0.05). Between baseline and 1 year in the healed bone group, all seven domains improved significantly compared with only three domains in the extraction group. However, the overall OHIP-14 score between groups was not substantially different. Hence, both treatment modalities lead to similar OHRQoL improvement. Patients in need of a single-tooth replacement have limited OHRQoL problems as reflected by the OHIP-14 score but improvements in several domains related to oral health were evaluated when implants were placed and provisionalized in healed bone and extraction sites.

Squamous Cell Carcinomas Are Associated With Verrucokeratotic Cutaneous Lesions But Not With Common Warts in Organ-Transplant Patients. A Case-Control Study

Warts are thought to be associated with the development of squamous cell carcinoma (SCC) in organ transplant patients. We investigated the association between the different types of warts and SCC in organ transplant patients. A prospective multicenter case-control study was conducted. Cases were patients with a kidney or heart transplant who were referred for a SCC. Controls were organ transplant patients without SCC, individually matched for age, gender, type of organ transplant (heart or kidney), skin phototype, time from transplantation, and center. Four types of warts: flat warts, verrucae vulgares (including palmo-plantar warts and common warts), verrucous papilloma, and verrucokeratotic lesions were compared between cases and controls using conditional logistic regression. Ninety-nine cases and 169 controls were included. In multivariate analysis, number of rejections, azathioprine, prednisolone and anti-lymphocyte anti-serum or anti-CD3 monoclonal antibodies use, cumulative sun exposure, actinic keratosis, and verrucokeratic lesions (odds ratio [OR] 16.50; 95% confidence interval [CI] 2.82-96.80) were independently associated with SCC, whereas the association with verrucous papilloma was borderline significant (OR 2.21; 95% CI 0.97-8.15). The association between the presence of at least one of these two types of warts (verruco-keratotic lesions and verrucous papilloma) and the occurrence of SCC was highly significant (OR 18.36; 95% CI 3.03-111) when these warts were located in the same area than SCC, whereas no significant association was evidenced when these warts were located in another area (OR 1.02; 95% CI 0.13-5.79). Verrucous papilloma and mainly verrucokeratotic lesions are strongly associated with the risk of SCC in organ transplant patients, whereas the most typical types of warts: verrucae vulgares and flat warts, are not.

Sentinel-node biopsy before or after neoadjuvant systemic treatment: The German SENTINA trial.

TPS114 Background: For patients with breast cancer undergoing neoadjuvant systemic treatment (NST) the optimal timing of sentinel-node biopsy (SLNB) is unclear. While adequate axillary staging prior to NST could allow for a priori tailoring of systemic treatment, SLNB after NST could spare those patients from complete axillary dissection (AD), who are free of metastases in the axilla or convert from a positive (Npos) to a negative (Nneg) axillary status following NST. For these patients, however, the reliability of SLNB to predict the axillary status remains yet to be prospectively confirmed. Methods: The German SENTINA protocol, as a substudy of the German Geparquinto neoadjuvant trial of the AGO and the German Breast Group (GBG), is a 4-arm prospective multicenter case control study designed to examine the role of SLN in patients undergoing NST. Study objectives are: 1) to compare the detection rate of SLNB before and after NST; 2) to evaluate the number of patients with involved nodes despite being cli...

Cólico nefrítico en el servicio de urgencias: Estudio epidemiológico, diagnóstico y etiopatogénico

To investigate epidemiologic, etiopathogenic and clinical factors associated with emergency renal colic (RC). METHODS ANDS RESULTS: We performed a prospective cross-sectional multicenter case-control study of 146 patients treated for RC at emergency departments. Data collected included age, sex, localization/severity of pain, symptoms, personal/family medical history, urine analysis, etiopathogenic factors, chemical composition of the lithiasis, and x-ray studies. Comparative statistical analysis was performed using SPSS 12.2 software. RC was more frequent in men; maximum incidence was between 31-50 years for both sex, with 36.3% in men and 21.23% in women; 60.27% of patients rated pain as severe; 140 RC patients (95.89%) had urologic antecedents vs. 15 (10.27%) controls without RC (p<0.001). The most frequent presentation (93.83%) was sudden intense lumbar-abdominal or lumbar pain; 23.28% of RC patients had family history for urinary lithiasis vs. 6.16% controls (p<0,001). Most RC patients were seen during summer (36.58%), 82% of RC patients drank <2L of water daily vs. 18.49% in non-RC patients (p<0.001). Hematuria was found in 132 (90.41%) patients with RC vs. 17 (11.64%) in those without (p<0.001). Lithiasis was observed by KUB x-ray in 42.10% of RC patients vs. 57.89% controls, most frequent calculi composition was calcium oxalate monohydrate and dehydrate (61,2%). The incidence of urinary lithiasis and RC in our health care area shows a male predominance. The characteristic pain of RC is severe and appears suddenly. It starts in the back (lumbar region), below the ribs, radiating towards the groin and external genitals (testicles in man or major lips in woman) on the same side. Nausea and vomiting are frequent. Family history of urinary lithiasis and low water intake are risk factors that need to be investigated. Occupations associated with a sedentary life style or with a hot, dry workplace show a higher incidence of lithiasis. A hot, dry climate favours the formation of urinary lithiasis and the highest incidence of lithiasis is in the summer, during the months of July and August. The most frequent component of urolithiasis in our study, as well as in other studies, was calcium oxalate monohydrate and dihydrate.

Major Dietary Factors and Prostate Cancer Risk: A Prospective Multicenter Case-Control Study

The association between diet and prostate cancer (PC) risk, although suggestive, still remains largely elusive particularly in the Asian population. This study sought to further evaluate the possible effects of different dietary factors on risk of PC in Iran. Using data from a prospective hospital-based multicenter case-control study, dietary intakes of red meat, fat, garlic, and tomato/tomato products, as well as thorough demographic and medical characteristics, were determined in 194 cases with the newly diagnosed, clinicopathologically confirmed PC and 317 controls, without any malignant disease, admitted to the same network of hospitals. Odds ratios (ORs) and corresponding 95% confidence intervals (CIs) were obtained after adjustment for major potential confounders, including age, body mass index, smoking, alcohol, education, occupation, family history of PC, and total dietary calories. Comparing the highest with the lowest tertile, a significant trend of increasing risk with more frequent consumption was found for dietary fat (OR: 1.79, 95% CI: 1.71–4.51), whereas inverse association was observed for tomato/tomato products (OR: 0.33, 95% CI: 0.16–0.65). A nonsignificant increase in PC risk was revealed for dietary red meat (OR: 1.69, 95% CI: 0.93–3.06). For garlic consumption, a borderline reduction in risk was observed (OR: 0.58, 95% CI: 0.32–1.01; P = 0.05). In conclusion, our study supports the hypothesis that total fat may increase PC risk and tomatoes/tomato products and garlic may protect patients against PC.

SENTinel Node Biopsy before or after NeoAdjuvant Systemic Treatment – The German SENTINA Trial.

Abstract Background: For patients with breast cancer undergoing neoadjuvant systemic treatment (NST) the optimal timing of sentinel node biopsy (SLNB) is unclear. While adequate axillary staging prior to NST could allow for a-priori tailoring of systemic treatment, SLNB after NST could spare those patients from complete axillary dissection (AD), who are free of metastases in the axilla or convert from a positive (Npos) to a negative (Nneg) axillary status following NST. For these patients, however, the reliability of SLNB to predict the axillary status remains yet to be prospectively confirmed.Material and Methods: The German SENTINA protocol, as a substudy of the German Geparquinto neoadjuvant trial of the AGO and the German Breast Group (GBG), is a 4-arm prospective multicenter case control study designed to examine the role of SLN in patients undergoing NST.Study design:Arm A before NST: clinically Nneg + negative SLN --&amp;gt; no add. Axillary surgery Arm B before NST: clinically Nneg + positive SLN --&amp;gt; sentinel-node-guided AD after NST Arm C before NST: clinically Npos, after NST: clinically Nneg --&amp;gt; sentinel-node-guided AD after NST Arm D before NST: clinically Npos, after NST: clinically Npos --&amp;gt; ADStudy objectives:1. to compare the detection rate of SLNB before and after NST2. to evaluate the number of patients with involved nodes despite being clinically Nneg before NST3. to determine the number of patients who convert from clinically Npos to histologically Nneg after NST4. to evaluate the false-negative rate of SNB for patients who convert from clinically Npos to histologically SNneg after NST5. to determine lymphatic pathway configuration, detection rate and false-negative rate of SLNB after prior SLNB6. to determine the false negative rate of intraoperative frozen section before and after NSTResults: Until now 366 patients from 30 institutions have been enrolled in this trial. 230 patients have completed primary systemic and surgical treatment. A total of 1508 patients were calculated as adequate to have the one-sided confidence interval of 95 % for the false negative rate of SLNB in the arms B and C not exceeding 10% (196 pts each). 82 pts entered arm A. Fifty-eight, 76 and 24 pts were recruited for the arms B, C and D respectively.Conclusion: To our knowledge the SENTINA trial is the first prospective multicenter study to evaluate the role of SLNB in the neoadjuvant setting. The SENTINA protocol will allow for a direct comparison of the feasibility and reproducibility of a standardized SLNB-procedure before and after NST. The study will provide reliable data on the predictive value of SLNB before and after NST in patients converting from a clinically positive to a negative axillary status and offer insights into the biology of axillary response to NST. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 1008.

Beneficial effects of Waon therapy on patients with chronic heart failure: Results of a prospective multicenter study

We conducted a prospective multicenter case-control study to confirm the clinical efficacy and safety of Waon therapy on chronic heart failure (CHF). Patients (n=188) with CHF were treated with standard therapy for at least 1 week, and then were randomized to Waon therapy (n=112) or a control group (n=76). All patients continued conventional treatment for an additional 2 weeks. The Waon therapy group was treated daily with a far infrared-ray dry sauna at 60 degrees C for 15 min and then kept on bed rest with a blanket for 30 min for 2 weeks. Chest radiography, echocardiography, and plasma levels of brain natriuretic peptide (BNP) were measured before and 2 weeks after treatment. NYHA functional class significantly decreased after 2 weeks of treatment in both groups. Chest radiography also showed a significant decrease of the cardiothoracic ratio in both groups (Waon therapy: 57.2+/-8.0% to 55.2+/-8.0%, p<0.0001; control: 57.0+/-7.7% to 56.0+/-7.1%, p<0.05). Echocardiography demonstrated that left ventricular diastolic dimension (LVDd), left atrial dimension (LAD), and ejection fraction (EF) significantly improved in the Waon therapy group (LVDd: 60.6+/-7.6 to 59.1+/-8.4 mm, p<0.0001; LAD: 45.4+/-9.3 mm to 44.1+/-9.4 mm, p<0.05; EF: 31.6+/-10.4% to 34.6+/-10.6%, p<0.0001), but not in the control group (LVDd: 58.4+/-10.3 mm to 57.9+/-10.4 mm; LAD: 46.3+/-9.7 mm to 46.2+/-10.1 mm; EF: 36.6+/-14.1% to 37.3+/-14.0%). The plasma concentration of BNP significantly decreased with Waon therapy, but not in the control group (Waon: 542+/-508 pg/ml to 394+/-410 pg/ml, p<0.001; control: 440+/-377 pg/ml to 358+/-382 pg/ml). Waon therapy is safe, improves clinical symptoms and cardiac function, and decreases cardiac size in CHF patients. Waon therapy is an innovative and promising therapy for patients with CHF.

Risk factors associated with falls among Chinese hospital inpatients in Taiwan

Falls among hospital inpatients were not uncommon and were associated with physical, functional and psychological morbidity for patients and excess cost, bed occupancy, complaints and litigation for hospitals. Risk factors for falls of hospital inpatients have been reported, but rarely in a case–control design. To our best knowledge, there was no case–control study for risk of fall among hospital inpatients in Taiwan, one of the most rapidly aging countries. The main purpose of this study was to determine risk factors for falls among hospital inpatients in Taiwan. A prospective multi-center case–control study was started in 2002. During the study period, all incident falls reported by ward nurses were carefully reviewed by research staff on the next day, and a matched control subject was generated according to the age, sex, diagnosis, and pre-event length of stay. Risk factors of falls, including physical conditions, pharmaceutical agents, and environmental factors were compared between fallers and controls. In total, 202 incident falls (202 fallers, none of them fell twice, mean age: 68.2 ± 16.9 years, 73.8% males) were reported and the overall incidence of falls during the study period was 4.4 per 1000 bed days. Leg weakness (odds ratio (OR): 1.88, 95% confidence interval (CI): 1.16–3.05), reported insomnia at admission (OR: 2.28; 95% CI: 1.06–4.89), postural hypotension (OR: 5.57; 95% CI: 1.54–21.46), previous history of fall within 1 year before admissions (OR: 5.05, CI: 2.60–9.78), recent use of hypnotics (within 24 h) (OR: 1.86, 95% CI: 1.10–3.14) were all significant risk factors (for all comparisons p < 0.05), but family member's company may reduce in-hospital falls (OR: 0.51; 95% CI: 0.33–0.78). In conclusion, the incidence of falls among hospital inpatients was lower than that reported from other countries. Further study is needed to organize a comprehensive fall prevention program according to the risk factors identified in this study to reduce in-hospital falls in Taiwan.

Long-Term Outcome After Primary Stenting Versus Balloon Angioplasty for Acute Myocardial Infarction Five-year Follow-up of a Case-control Study

The objective of the present prospective multicenter case-control study was to investigate the long-term clinical outcome (5 years) of primary stenting compared to primary percutaneous transluminal coronary angioplasty (PTCA) without stenting (POBA) in patients with acute myocardial infarction at 7 cardiovascular centers in Hokkaido, Japan. Forty-one patients with acute myocardial infarction treated with successful primary stenting (stent group: case) and paired with 41 matched control subjects with acute myocardial infarction treated by successful primary PTCA without stenting (POBA group: control) were analyzed. After 1 year, the stent group had a lower incidence of the combined clinical endpoint (death, rehospitalization due to congestive heart failure, nonfatal myocardial infarction, repeat angioplasty, CABG, or cerebrovascular events) compared to the POBA group (17.1% versus 39.0%, P = 0.049). After 5 years, the incidences of congestive heart failure and cardiac death were the same in both groups. However, compared to the POBA group, the stent group had a lower combined clinical endpoint (34.1% versus 61.0%, P = 0.027). The Kaplan-Meier event-free survival curves of the stent group showed a significantly lower occurrence of clinical events compared to the POBA group (P = 0.0116). Multiple logistic regression analysis of clinical events identified age > or = 69 years (P = 0.0092, odds ratio = 4.179) and stenting (P = 0.0158, odds ratio = 0.279) as explanatory factors. Compared with POBA, primary stenting for acute myocardial infarction results in a better long-term clinical outcome.

Multicenter case-control study of risk factors associated with development of vaccine-associated sarcomas in cats.

To determine whether particular vaccine brands, other injectable medications, customary vaccination practices, or various host factors were associated with the formation of vaccine-associated sarcomas in cats. Prospective multicenter case-control study. Cats in the United States and Canada with soft tissue sarcomas or basal cell tumors. Veterinarians submitting biopsy specimens from cats with a confirmed diagnosis of soft tissue sarcoma or basal cell tumor were contacted for patient medical history. Time window statistical analyses were used in conjunction with various assumptions about case definitions. No single vaccine brand or manufacturer within antigen class was found to be associated with sarcoma formation. Factors related to vaccine administration were also not associated with sarcoma development, with the possible exception of vaccine temperature prior to injection. Two injectable medications (long-acting penicillin and methyl prednisolone acetate) were administered to case cats more frequently than to control cats. Findings do not support the hypotheses that specific brands or types of vaccine within antigen class, vaccine practices such as reuse of syringes, concomitant viral infection, history of trauma, or residence either increase or decrease the risk of vaccine-associated sarcoma formation in cats. There was evidence to suggest that certain long-acting injectable medications may also be associated with sarcoma formation.

High endometrial aromatase P450 messenger RNA expression is associated with poor IVF outcome

Objective: The success of IVF treatment is thought to be dependent upon embryo quality and endometrial receptivity. Previous reports indicated that expression of aromatase P450 in the endometrium is restricted to women with proliferative reproductive tract disorders such as endometriosis, leiomyomas, and adenomyosis. The aim of this study was to determine if the level of endometrial aromatase P450 mRNA expression is a determinant of IVF outcome in infertile women.Design: A prospective multicenter case-control study.Setting: Eight European IVF units and a university center for reproductive research.Patients: A hundred twenty patients awaiting IVF treatment.Intervention(s): Endometrial biopsy prior to starting IVF treatment.Main Outcome Measures: Endometrial aromatase P450 and GAPDH transcripts were quantified by real-time RT-PCR using an ABI PRISM 7700 Sequence Detection System.Results: Aromatase P450 transcripts were detected in all endometria examined, although the levels varied considerably between samples ranging from 0.22 (arbitrary units, a.u.) to 486.6 a.u. (>2000 fold difference). The mean aromatase P450 mRNA level (±S.D.) in women who subsequently became pregnant after IVF treatment was 3.7 (±3.7) compared to 14.3 (±52.5) in patients with IVF failure (p > 0.05). The clinical pregnancy rate in women with high endometrial aromatase P450 mRNA levels (≥ 8.2 a.u.; n = 19) was 5.5% versus 22.8% in those patients with low expression levels (<8.2 a.u.; n = 101) (p < 0.05). The cycle day of the endometrial biopsy, cause of infertility, age, parity, number of oocytes collected, or number of embryos transferred did not differ between patients with high versus low endometrial aromatase P450 mRNA levels (p > 0.1).Conclusion: Quantitation of endometrial P450 mRNA levels is a potential diagnostic tool to identify women with high likelihood of IVF treatment failure. Objective: The success of IVF treatment is thought to be dependent upon embryo quality and endometrial receptivity. Previous reports indicated that expression of aromatase P450 in the endometrium is restricted to women with proliferative reproductive tract disorders such as endometriosis, leiomyomas, and adenomyosis. The aim of this study was to determine if the level of endometrial aromatase P450 mRNA expression is a determinant of IVF outcome in infertile women. Design: A prospective multicenter case-control study. Setting: Eight European IVF units and a university center for reproductive research. Patients: A hundred twenty patients awaiting IVF treatment. Intervention(s): Endometrial biopsy prior to starting IVF treatment. Main Outcome Measures: Endometrial aromatase P450 and GAPDH transcripts were quantified by real-time RT-PCR using an ABI PRISM 7700 Sequence Detection System. Results: Aromatase P450 transcripts were detected in all endometria examined, although the levels varied considerably between samples ranging from 0.22 (arbitrary units, a.u.) to 486.6 a.u. (>2000 fold difference). The mean aromatase P450 mRNA level (±S.D.) in women who subsequently became pregnant after IVF treatment was 3.7 (±3.7) compared to 14.3 (±52.5) in patients with IVF failure (p > 0.05). The clinical pregnancy rate in women with high endometrial aromatase P450 mRNA levels (≥ 8.2 a.u.; n = 19) was 5.5% versus 22.8% in those patients with low expression levels (<8.2 a.u.; n = 101) (p < 0.05). The cycle day of the endometrial biopsy, cause of infertility, age, parity, number of oocytes collected, or number of embryos transferred did not differ between patients with high versus low endometrial aromatase P450 mRNA levels (p > 0.1). Conclusion: Quantitation of endometrial P450 mRNA levels is a potential diagnostic tool to identify women with high likelihood of IVF treatment failure.