Impact of neurocognition on social and role functioning in individuals at clinical high risk for psychosis.

PubMed

Carrión, Ricardo E; Goldberg, Terry E; McLaughlin, Danielle; Auther, Andrea M; Correll, Christoph U; Cornblatt, Barbara A

2011-08-01

Cognitive deficits have been well documented in schizophrenia and have been shown to impair quality of life and to compromise everyday functioning. Recent studies of adolescents and young adults at high risk for developing psychosis show that neurocognitive impairments are detectable before the onset of psychotic symptoms. However, it remains unclear how cognitive impairments affect functioning before the onset of psychosis. The authors assessed cognitive impairment in adolescents at clinical high risk for psychosis and examined its impact on social and role functioning. A sample of 127 treatment-seeking patients at clinical high risk for psychosis and a group of 80 healthy comparison subjects were identified and recruited for research in the Recognition and Prevention Program. At baseline, participants were assessed with a comprehensive neurocognitive battery as well as measures of social and role functioning. Relative to healthy comparison subjects, clinical high-risk patients showed significant impairments in the domains of processing speed, verbal memory, executive function, working memory, visuospatial processing, motor speed, sustained attention, and language. Clinical high-risk patients also displayed impaired social and role functioning at baseline. Among patients with attenuated positive symptoms, processing speed was related to social and role functioning at baseline. These findings demonstrate that cognitive and functional impairments are detectable in patients at clinical high risk for psychosis before the onset of psychotic illness and that processing speed appears to be an important cognitive predictor of poor functioning.

Premorbid functional development and conversion to psychosis in clinical high-risk youths

PubMed Central

Tarbox, Sarah I.; Addington, Jean; Cadenhead, Kristin S.; Cannon, Tyrone D.; Cornblatt, Barbara A.; Perkins, Diana O.; Seidman, Larry J.; Tsuang, Ming T.; Walker, Elaine F.; Heinssen, Robert; Mcglashan, Thomas H.; Woods, Scott W.

2014-01-01

Deterioration in premorbid functioning is a common feature of schizophrenia, but sensitivity to psychosis conversion among clinical high-risk samples has not been examined. This study evaluates premorbid functioning as a predictor of psychosis conversion among a clinical high-risk sample, controlling for effects of prior developmental periods. Participants were 270 clinical high-risk individuals in the North American Prodrome Longitudinal Study—I, 78 of whom converted to psychosis over the next 2.5 years. Social, academic, and total maladjustment in childhood, early adolescence, and late adolescence were rated using the Cannon–Spoor Premorbid Adjustment Scale. Early adolescent social dysfunction significantly predicted conversion to psychosis (hazard ratio = 1.30, p = .014), independently of childhood social maladjustment and independently of severity of most baseline positive and negative prodromal symptoms. Baseline prodromal symptoms of disorganized communication, social anhedonia, suspiciousness, and diminished ideational richness mediated this association. Early adolescent social maladjustment and baseline suspiciousness together demonstrated moderate positive predictive power (59%) and high specificity (92.1%) in predicting conversion. Deterioration of academic and total functioning, although observed, did not predict conversion to psychosis. Results indicate early adolescent social dysfunction to be an important early predictor of conversion. As such, it may be a good candidate for inclusion in prediction algorithms and could represent an advantageous target for early intervention. PMID:24229556

Temporal association of cannabis use with symptoms in individuals at clinical high risk for psychosis.

PubMed

Corcoran, Cheryl M; Kimhy, David; Stanford, Arielle; Khan, Shamir; Walsh, Julie; Thompson, Judy; Schobel, Scott; Harkavy-Friedman, Jill; Goetz, Ray; Colibazzi, Tiziano; Cressman, Victoria; Malaspina, Dolores

2008-12-01

Cannabis use is reported to increase the risk for psychosis, but no prospective study has longitudinally examined drug use and symptoms concurrently in clinical high risk cases. We prospectively followed for up to 2 years 32 cases who met research criteria for prodromal psychosis to examine the relationship between substance use and clinical measures. Cases with a baseline history of cannabis use (41%) were older, but did not differ in clinical measures. Longitudinal assessments showed these cases had significantly more perceptual disturbances and worse functioning during epochs of increased cannabis use that were unexplained by concurrent use of other drugs or medications. These data demonstrate that cannabis use may be a risk factor for the exacerbation of subthreshold psychotic symptoms, specifically perceptual disturbances, in high risk cases.

Management of Skin Cancer in the High-Risk Patient.

PubMed

Behan, James W; Sutton, Adam; Wysong, Ashley

2016-12-01

Skin cancer is the most common of human cancers and outnumbers all other types of cancer combined in the USA by over threefold. The majority of non-melanoma skin cancers are easily treated with surgery or locally destructive techniques performed under local anesthesia in the cost-effective outpatient setting. However, there is a subset of "high-risk" cases that prove challenging in terms of morbidity, mortality, adjuvant treatment required, as well as overall cost to the health care system. In our opinion, the term "high risk" when applied to skin cancer can mean one of three things: a high-risk tumor with aggressive histologic and/or clinical features with an elevated risk for local recurrence or regional/distant metastasis, a high-risk patient with the ongoing development of multiple skin cancers, and a high-risk patient based on immunosuppression. We have recently proposed classifying NMSC as a chronic disease in a certain subset of patients. Although no consensus definition exists for a chronic disease in medicine, there are three components that are present in most definitions: duration of at least 1 year, need for ongoing medical care, and functional impairment and/or alteration of activities of daily living (ADLs) and quality of life (QOL). Immunosuppression can refer to exogenous (organ or stem cell transplant patients,) or endogenous (HIV, leukemia, lymphoma, genodermatoses with DNA mismatch repair problems or other immunosuppression) causes. These patients are at risk for high-risk tumors and/or the development of multiple tumors.

Complete surgical resection improves outcome in INRG high-risk patients with localized neuroblastoma older than 18 months.

PubMed

Fischer, Janina; Pohl, Alexandra; Volland, Ruth; Hero, Barbara; Dübbers, Martin; Cernaianu, Grigore; Berthold, Frank; von Schweinitz, Dietrich; Simon, Thorsten

2017-08-04

Although several studies have been conducted on the role of surgery in localized neuroblastoma, the impact of surgical timing and extent of primary tumor resection on outcome in high-risk patients remains controversial. Patients from the German neuroblastoma trial NB97 with localized neuroblastoma INSS stage 1-3 age > 18 months were included for retrospective analysis. Imaging reports were reviewed by two independent physicians for Image Defined Risk Factors (IDRF). Operation notes and corresponding imaging reports were analyzed for surgical radicality. The extent of tumor resection was classified as complete resection (95-100%), gross total resection (90-95%), incomplete resection (50-90%), and biopsy (<50%) and correlated with local control rate and outcome. Patients were stratified according to the International Neuroblastoma Risk Group (INRG) staging system. Survival curves were estimated according to the method of Kaplan and Meier and compared by the log-rank test. A total of 179 patients were included in this study. 77 patients underwent more than one primary tumor operation. After best surgery, 68.7% of patients achieved complete resection of the primary tumor, 16.8% gross total resection, 14.0% incomplete surgery, and 0.5% biopsy only. The cumulative complication rate was 20.3% and the surgery associated mortality rate was 1.1%. Image defined risk factors (IDRF) predicted the extent of resection. Patients with complete resection had a better local-progression-free survival (LPFS), event-free survival (EFS) and OS (overall survival) than the other groups. Subgroup analyses showed better EFS, LPFS and OS for patients with complete resection in INRG high-risk patients. Multivariable analyses revealed resection (complete vs. other), and MYCN (non-amplified vs. amplified) as independent prognostic factors for EFS, LPFS and OS. In patients with localized neuroblastoma age 18 months or older, especially in INRG high-risk patients harboring MYCN amplification

Adjuvant chemoradiotherapy instead of revision radical resection after local excision for high-risk early rectal cancer.

PubMed

Jeong, Jae-Uk; Nam, Taek-Keun; Kim, Hyeong-Rok; Shim, Hyun-Jeong; Kim, Yong-Hyub; Yoon, Mee Sun; Song, Ju-Young; Ahn, Sung-Ja; Chung, Woong-Ki

2016-09-05

After local excision of early rectal cancer, revision radical resection is recommended for patients with high-risk pathologic stage T1 (pT1) or pT2 cancer, but the revision procedure has high morbidity rates. We evaluated the efficacy of adjuvant concurrent chemoradiotherapy (CCRT) for reducing recurrence after local excision in these patients. Eighty-three patients with high-risk pT1 or pT2 rectal cancer underwent postoperative adjuvant CCRT after local excision. We defined high-risk features as pT1 having tumor size ≤3 cm, and/or resection margin (RM) ≤3 mm, and/or lymphovascular invasion (LVI), and/or non-full thickness excision such as endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD), or unknown records regarding those features, or pT2 cancer. Radiotherapy was administered with a median dose of 50.4 Gy in 1.8 Gy fraction size over 5-7 weeks. Concurrent 5-fluorouracil and leucovorin were administered for 4 days in the first and fifth weeks of radiotherapy. The median interval between local excision and radiotherapy was 34 (range, 11-104) days. Fifteen patients (18.1 %) had stage pT2 tumors, 22 (26.5 %) had RM of ≥3 mm, and 21 (25.3 %) had tumors of ≥3 cm in size. Thirteen patients (15.7 %) had LVI. Transanal excision was performed in 58 patients (69.9 %) and 25 patients (30.1 %) underwent EMR or ESD. The median follow-up was 61 months. The 5-year overall survival (OS), locoregional relapse-free survival (LRFS), and disease-free survival (DFS) rates for all patients were 94.9, 91.0, and 89.8 %, respectively. Multivariate analysis did not identify any significant factors for OS or LRFS, but the only significant factor affecting DFS was the pT stage (p = 0.027). In patients with high-risk pT1 rectal cancer, adjuvant CCRT after local excision could be an effective alternative treatment instead of revision radical resection. However, patients with pT2 stage showed inferior DFS compared to pT1.

Endocrine therapy for breast cancer prevention in high-risk women: clinical and economic considerations.

PubMed

Groom, Amy G; Younis, Tallal

2016-01-01

The global burden of breast cancer highlights the need for primary prevention strategies that demonstrate both favorable clinical benefit/risk profile and good value for money. Endocrine therapy with selective estrogen-receptor modulators (SERMs) or aromatase inhibitors (AIs) has been associated with a favorable clinical benefit/risk profile in the prevention of breast cancer in women at high risk of developing the disease. The available endocrine therapy strategies differ in terms of their relative reductions of breast cancer risk, potential side effects, and upfront drug acquisition costs, among others. This review highlights the clinical trials of SERMs and AIs for the primary prevention of breast cancer, and the cost-effectiveness /cost-utility studies that have examined their "value for money" in various health care jurisdictions.

Clinical outcomes of image guided radiation therapy (IGRT) with gold fiducial vaginal cuff markers for high-risk endometrial cancer.

PubMed

Monroe, Alan T; Pikaart, Dirk; Peddada, Anuj V

2013-06-01

To report two year clinical outcomes of image guided radiation therapy (IGRT) to the vaginal cuff and pelvic lymph nodes in a series of high-risk endometrial cancer patients. Twenty-six consecutive high-risk endometrial cancer patients requiring adjuvant radiation to the vaginal cuff and regional lymph nodes were treated with vaginal cuff fiducial-based IGRT. Seventeen (65%) received sequential chemotherapy, most commonly with a sandwich technique. Brachytherapy followed external radiation in 11 patients to a median dose of 18 Gy in 3 fractions. The median external beam dose delivered was 47.5 Gy in 25 fractions. All 656 fractions were successfully imaged and treated. The median overall translational shift required for correction was 9.1 mm (standard deviation, 5.2 mm) relative to clinical set-up with skin tattoos. Shifts of 1 cm, 1.5 cm, and 2 cm or greater were performed in 43%, 14%, and 4% of patients, respectively. Acute grade 2 gastrointestinal (GI) toxicity occurred in eight patients (30%) and grade 3 toxicity occurred in one. At two years, there have been no local or regional failures and actuarial overall survival is 95%. Daily image guidance for high-risk endometrial cancer results in a low incidence of acute GI/genitourinary (GU) toxicity with uncompromised tumor control at two years. Vaginal cuff translations can be substantial and may possibly result in underdosing if not properly considered.

Introduction of high risk pregnancy care in rural Cameroon: health service research approach.

PubMed

Leke, R J; Nasah, B T; Mtango, F D

1988-05-01

A 3-year study (1982-1985) in Cameroon showed that high-risk pregnancy identification and care could successfully be introduced in rural communities through inexpensive training and supervision of local nurses, particularly when motivation for use of antenatal clinics (ANCs) was provided by the local Community Women's Organization (CWO). 11 communities, all rural except Tsinga, were randomly allocated to Groups I (control) or II. A retrospective baseline survey of ANCs showed that high-risk pregnancy detection had been nonexistent. For both groups, nurses were given 2-week training courses on high-risk identification and family planning. The registers for recording prenatal consultations and deliveries were modified to include recording of risk factors. Special forms were created for reporting on each high-risk case thus identified. These forms proved more difficult for the nurses to complete than the registers. For Group II communities, CWO leaders were recruited to urge women to attend ANCs. 2548 cases of high-risk pregnancy (21.9% of pregnancies) were identified on the special forms, although the number of cases identified in clinic registers was consistently higher. Posttest attendance at ANCs was higher than pretest and significantly higher in areas where CWO motivation had been used. Major risk factors in the identified cases were grand multiparity, teenage pregnancy and previous complicated obstetrics history, although semiurban Tsinga had less grand multiparity and teenage pregnancy and more obesity, diabetes, hypertension and preclampsia. Only 23.4% of the identified cases delivered in the clinics, showing the need for more comprehensive maternal service programs. Since only 5% of the high-risk pregnancy population accepted modern contraceptives after delivery, research is needed on the determinants.

Clinical predictors of high risk histopathology in retinoblastoma.

PubMed

Kashyap, Seema; Meel, Rachna; Pushker, Neelam; Sen, Seema; Bakhshi, Sameer; Sreenivas, Vishnubhatla; Sethi, Sumita; Chawla, Bhavna; Ghose, Supriyo

2012-03-01

Previous studies show that clinical features at presentation, in retinoblastoma patients, like glaucoma and neovascularization of iris are associated with a higher incidence of high risk histopathology findings (HRF) in enucleated eyes. Herein, we analyze association between clinical features at time of enucleation and occurrence of HRF including invasion of anterior chamber, iris, ciliary body, choroid (massive), sclera, extrascleral tissue, optic nerve beyond lamina cribrosa, and optic nerve cut end, in a large series of eyes enucleated for retinoblastoma. We retrospectively studied demographic, clinical, and histopathology findings in all retinoblastoma patients who underwent primary enucleation at our center, over a 5 years duration. Statistical analysis was done to find any association between clinical features at presentation and the presence of HRF. Three hundred twenty-six eyes were studied. Median age of presentation was 2 years. Glaucoma was the most common clinical finding at presentation apart from leucocoria. Out of 326 enucleated eyes, 28 (8.6%) had extrascleral and/or optic nerve transection invasion. Among remaining 298 eyes, with completely resected tumor, 115 (38.6%) had massive choroidal invasion, 54 (17%) had retrolaminar optic nerve invasion, and 24 (7%), 29 (9%), and 23(7%) had anterior chamber, iris, and ciliary body invasion, respectively. Age more than 2 years, lag period more than 3 months, hyphema, pseudohypopyon, staphyloma, and orbital cellulitis were associated with occurrence of three or more HRF on univariate analysis. Clinical variables including older age, longer lag period, hyphema, pseudohypopyon, staphyloma, and orbital cellulitis were strongly associated with occurrence of HRF in this study. Copyright © 2011 Wiley Periodicals, Inc.

Pharmacodynamic and pharmacokinetic neoadjuvant study of hedgehog pathway inhibitor Sonidegib (LDE-225) in men with high-risk localized prostate cancer undergoing prostatectomy.

PubMed

Ross, Ashley E; Hughes, Robert M; Glavaris, Stephanie; Ghabili, Kamyar; He, Ping; Anders, Nicole M; Harb, Rana; Tosoian, Jeffrey J; Marchionni, Luigi; Schaeffer, Edward M; Partin, Alan W; Allaf, Mohamad E; Bivalacqua, Trinity J; Chapman, Carolyn; O'Neal, Tanya; DeMarzo, Angelo M; Hurley, Paula J; Rudek, Michelle A; Antonarakis, Emmanuel S

2017-11-28

To determine the pharmacodynamic effects of Sonidegib (LDE-225) in prostate tumor tissue from men with high-risk localized prostate cancer, by comparing pre-surgical core-biopsy specimens to tumor tissue harvested post-treatment at prostatectomy. We conducted a prospective randomized (Sonidegib vs. observation) open-label translational clinical trial in men with high-risk localized prostate cancer undergoing radical prostatectomy. The primary endpoint was the proportion of patients in each arm who achieved at least a two-fold reduction in GLI1 mRNA expression in post-treatment versus pre-treatment tumor tissue. Secondary endpoints included the effect of pre-surgical treatment with Sonidegib on disease progression following radical prostatectomy, and safety. Fourteen men were equally randomized (7 per arm) to either neoadjuvant Sonidegib or observation for 4 weeks prior to prostatectomy. Six of seven men (86%) in the Sonidegib arm (and none in the control group) achieved a GLI1 suppression of at least two-fold. In the Sonidegib arm, drug was detectable in plasma and in prostatic tissue; and median intra-patient GLI1 expression decreased by 63-fold, indicating potent suppression of Hedgehog signaling. Sonidegib was well tolerated, without any Grade 3-4 adverse events observed. Disease-free survival was comparable among the two arms (HR = 1.50, 95% CI 0.26-8.69, P = 0.65). Hedgehog pathway activity (as measured by GLI1 expression) was detectable at baseline in men with localized high-risk prostate cancer. Sonidegib penetrated into prostatic tissue and induced a >60-fold suppression of the Hedgehog pathway. The oncological benefit of Hedgehog pathway inhibition in prostate cancer remains unclear.

[Clinical features and magnetic resonance imaging evaluation of encephalopathy in high-risk late preterm infants].

PubMed

Zhu, Yan; Zhang, Ke; Hu, Lan; Xiao, Mi-Li; Li, Zhi-Hua; Chen, Chao

2017-05-01

To investigate the risk factors, clinical features, and magnetic resonance imaging (MRI) changes of encephalopathy in high-risk late preterm infants. Head MRI scan was performed for late preterm infants with high-risk factors for brain injury who were hospitalized between January 2009 and December 2014. The risk factors, clinical features, and head MRI features of encephalopathy in late preterm infants were analyzed. A total of 1 007 late preterm infants underwent MRI scan, among whom 313 (31.1%) had imaging features in accordance with the features of encephalopathy of prematurity. Of all infants, 76.7% had white matter damage. There was no association between the development of encephalopathy and gestational age in late preterm infants, but the detection rate of encephalopathy gradually increased with the increasing birth weight (P<0.05). The logistic regression analysis showed that a history of resuscitation was an independent risk factor for encephalopathy of prematurity (P<0.01). Encephalopathy of prematurity is commonly seen in high-risk late preterm infants, especially white matter damage. A history of resuscitation is an independent risk factor for encephalopathy in late preterm infants.

Association between traditional clinical high-risk features and gene expression profile classification in uveal melanoma.

PubMed

Nguyen, Brandon T; Kim, Ryan S; Bretana, Maria E; Kegley, Eric; Schefler, Amy C

2018-02-01

To evaluate the association between traditional clinical high-risk features of uveal melanoma patients and gene expression profile (GEP). This was a retrospective, single-center, case series of patients with uveal melanoma. Eighty-three patients met inclusion criteria for the study. Patients were examined for the following clinical risk factors: drusen/retinal pigment epithelium (RPE) changes, vascularity on B-scan, internal reflectivity on A-scan, subretinal fluid (SRF), orange pigment, apical tumor height/thickness, and largest basal dimensions (LBD). A novel point system was created to grade the high-risk clinical features of each tumor. Further analyses were performed to assess the degree of association between GEP and each individual risk factor, total clinical risk score, vascularity, internal reflectivity, American Joint Committee on Cancer (AJCC) tumor stage classification, apical tumor height/thickness, and LBD. Of the 83 total patients, 41 were classified as GEP class 1A, 17 as class 1B, and 25 as class 2. The presence of orange pigment, SRF, low internal reflectivity and vascularity on ultrasound, and apical tumor height/thickness ≥ 2 mm were not statistically significantly associated with GEP class. Lack of drusen/RPE changes demonstrated a trend toward statistical association with GEP class 2 compared to class 1A/1B. LBD and advancing AJCC stage was statistically associated with higher GEP class. In this cohort, AJCC stage classification and LBD were the only clinical features statistically associated with GEP class. Clinicians should use caution when inferring the growth potential of melanocytic lesions solely from traditional funduscopic and ultrasonographic risk factors without GEP data.

Long-term outcomes of open radical retropubic prostatectomy for clinically localized prostate cancer in the prostate-specific antigen era.

PubMed

Dorin, Ryan P; Daneshmand, Siamak; Lassoff, Mark A; Cai, Jie; Skinner, Donald G; Lieskovsky, Gary

2012-03-01

To determine long-term oncological outcomes and complication rates for patients with clinically organ confined prostate adenocarcinoma (PCa) treated with open radical retropubic prostatectomy and pelvic lymph node dissection (RRP/PLND) in the prostate-specific antigen (PSA) era. Outcomes data were obtained from a prospectively maintained prostate cancer database. Patients with cT1/cT2 PCa undergoing RRP/PLND without neoadjuvant therapy between July 1988 and June 2008 were included. Kaplan-Meier and Cox proportional regression models were used to evaluate factors influencing biochemical recurrence, clinical recurrence, and overall survival (OS). A total of 2487 patients met inclusion criteria, and median follow-up was 7.2 years (range 1-21 years). Of the patients, 49.7% were low risk, 33.2% intermediate risk, and 16.1% high risk by D'Amico criteria, and 6% were LN+. The 10-year biochemical recurrence-free survival (BCRFS) for low-, intermediate-, and high-risk patients was 92%, 83%, and 76%, respectively (P < .001), and 10 year OS was 91%, 83%, and 74%, respectively (P < .001). BCRFS at 10 years was 76% and 88% for patients with positive and negative margins, respectively (P < .001). Of the 2487 patients, 11% developed BCR, and 3.7% experienced CR, with 9 local recurrences. The overall complication rate was 2.3%, and the cancer specific mortality rate was 2%. D'Amico risk group, margin status, and LN status are significantly correlated with outcomes in patients undergoing RRP/PLND for clinically localized PCa. Local recurrence and death from prostate cancer are rare in patients undergoing open RRP/PLND for clinically organ confined disease in the PSA era. Copyright © 2012 Elsevier Inc. All rights reserved.

Molecular markers to complement sentinel node status in predicting survival in patients with high-risk locally invasive melanoma.

PubMed

Rowe, Casey J; Tang, Fiona; Hughes, Maria Celia B; Rodero, Mathieu P; Malt, Maryrose; Lambie, Duncan; Barbour, Andrew; Hayward, Nicholas K; Smithers, B Mark; Green, Adele C; Khosrotehrani, Kiarash

2016-08-01

Sentinel lymph node status is a major prognostic marker in locally invasive cutaneous melanoma. However, this procedure is not always feasible, requires advanced logistics and carries rare but significant morbidity. Previous studies have linked markers of tumour biology to patient survival. In this study, we aimed to combine the predictive value of established biomarkers in addition to clinical parameters as indicators of survival in addition to or instead of sentinel node biopsy in a cohort of high-risk melanoma patients. Patients with locally invasive melanomas undergoing sentinel lymph node biopsy were ascertained and prospectively followed. Information on mortality was validated through the National Death Index. Immunohistochemistry was used to analyse proteins previously reported to be associated with melanoma survival, namely Ki67, p16 and CD163. Evaluation and multivariate analyses according to REMARK criteria were used to generate models to predict disease-free and melanoma-specific survival. A total of 189 patients with available archival material of their primary tumour were analysed. Our study sample was representative of the entire cohort (N = 559). Average Breslow thickness was 2.5 mm. Thirty-two (17%) patients in the study sample died from melanoma during the follow-up period. A prognostic score was developed and was strongly predictive of survival, independent of sentinel node status. The score allowed classification of risk of melanoma death in sentinel node-negative patients. Combining clinicopathological factors and established biomarkers allows prediction of outcome in locally invasive melanoma and might be implemented in addition to or in cases when sentinel node biopsy cannot be performed. © 2016 UICC.

Novel target for high-risk neuroblastoma identified in pre-clinical research | Center for Cancer Research

Cancer.gov

Pre-clinical research by investigators at the Center for Cancer Research and their colleagues have identified a number of novel epigenetic targets for high-risk neuroblastoma and validated a promising new targeted inhibitor in pre-clinical models.  Read more...

Frequent hospital admissions in Singapore: clinical risk factors and impact of socioeconomic status.

PubMed

Low, Lian Leng; Tay, Wei Yi; Ng, Matthew Joo Ming; Tan, Shu Yun; Liu, Nan; Lee, Kheng Hock

2018-01-01

Frequent admitters to hospitals are high-cost patients who strain finite healthcare resources. However, the exact risk factors for frequent admissions, which can be used to guide risk stratification and design effective interventions locally, remain unknown. Our study aimed to identify the clinical and sociodemographic risk factors associated with frequent hospital admissions in Singapore. An observational study was conducted using retrospective 2014 data from the administrative database at Singapore General Hospital, Singapore. Variables were identified a priori and included patient demographics, comorbidities, prior healthcare utilisation, and clinical and laboratory variables during the index admission. Multivariate logistic regression analysis was used to identify independent risk factors for frequent admissions. A total of 16,306 unique patients were analysed and 1,640 (10.1%) patients were classified as frequent admitters. On multivariate logistic regression, 16 variables were independently associated with frequent hospital admissions, including age, cerebrovascular disease, history of malignancy, haemoglobin, serum creatinine, serum albumin, and number of specialist outpatient clinic visits, emergency department visits, admissions preceding index admission and medications dispensed at discharge. Patients staying in public rental housing had a 30% higher risk of being a frequent admitter after adjusting for demographics and clinical conditions. Our study, the first in our knowledge to examine the clinical risk factors for frequent admissions in Singapore, validated the use of public rental housing as a sensitive indicator of area-level socioeconomic status in Singapore. These risk factors can be used to identify high-risk patients in the hospital so that they can receive interventions that reduce readmission risk. Copyright: © Singapore Medical Association

Reconsidering Clinical Staging Model: A Case of Genetic High Risk for Schizophrenia.

PubMed

Lee, Tae Young; Kim, Minah; Kim, Sung Nyun; Kwon, Jun Soo

2017-01-01

The clinical staging model is considered a useful and practical method not only in dealing with the early stage of psychosis overcoming the debate about diagnostic boundaries but also in emerging mood disorder. However, its one limitation is that it cannot discriminate the heterogeneity of individuals at clinical high risk for psychosis, but lumps them all together. Even a healthy offspring of schizophrenia can eventually show clinical symptoms and progress to schizophrenia under the influence of genetic vulnerability and environmental stress even after the peak age of onset of schizophrenia. Therefore, individuals with genetic liability of schizophrenia may require a more intensive intervention than recommended by the staging model based on current clinical status.

Clinical potentials of methylator phenotype in stage 4 high-risk neuroblastoma: an open challenge.

PubMed

Banelli, Barbara; Merlo, Domenico Franco; Allemanni, Giorgio; Forlani, Alessandra; Romani, Massimo

2013-01-01

Approximately 20% of stage 4 high-risk neuroblastoma patients are alive and disease-free 5 years after disease onset while the remaining experience rapid and fatal progression. Numerous findings underline the prognostic role of methylation of defined target genes in neuroblastoma without taking into account the clinical and biological heterogeneity of this disease. In this report we have investigated the methylation of the PCDHB cluster, the most informative member of the "Methylator Phenotype" in neuroblastoma, hypothesizing that if this epigenetic mark can predict overall and progression free survival in high-risk stage 4 neuroblastoma, it could be utilized to improve the risk stratification of the patients, alone or in conjunction with the previously identified methylation of the SFN gene (14.3.3sigma) that can accurately predict outcome in these patients. We have utilized univariate and multivariate models to compare the prognostic power of PCDHB methylation in terms of overall and progression free survival, quantitatively determined by pyrosequencing, with that of other markers utilized for the patients' stratification utilizing methylation thresholds calculated on neuroblastoma at stage 1-4 and only on stage 4, high-risk patients. Our results indicate that PCDHB accurately distinguishes between high- and intermediate/low risk stage 4 neuroblastoma in agreement with the established risk stratification criteria. However PCDHB cannot predict outcome in the subgroup of stage 4 patients at high-risk whereas methylation levels of SFN are suggestive of a "methylation gradient" associated with tumor aggressiveness as suggested by the finding of a higher threshold that defines a subset of patients with an extremely severe disease (OS <24 months). Because of the heterogeneity of neuroblastoma we believe that clinically relevant methylation markers should be selected and tested on homogeneous groups of patients rather than on patients at all stages.

Clinical decision making in a high-risk primary care environment: a qualitative study in the UK.

PubMed

Balla, John; Heneghan, Carl; Thompson, Matthew; Balla, Margaret

2012-01-01

Examine clinical reasoning and decision making in an out of hours (OOH) primary care setting to gain insights into how general practitioners (GPs) make clinical decisions and manage risk in this environment. Semi-structured interviews using open-ended questions. A 2-month qualitative interview study conducted in Oxfordshire, UK. 21 GPs working in OOH primary care. The most powerful themes to emerge related to dealing with urgent potentially high-risk cases, keeping patients safe and responding to their needs, while trying to keep patients out of hospital and the concept of 'fire fighting'. There were a number of well-defined characteristics that GPs reported making presentations easy or difficult to deal with. Severely ill patients were straightforward, while the older people, with complex multisystem diseases, were often difficult. GPs stopped collecting clinical information and came to clinical decisions when high-risk disease and severe illness requiring hospital attention has been excluded; they had responded directly to the patient's needs and there was a reliable safety net in place. Learning points that GPs identified as important for trainees in the OOH setting included the importance of developing rapport in spite of time pressures, learning to deal with uncertainty and learning about common presentations with a focus on critical cues to exclude severe illness. The findings support suggestions that improvements in primary care OOH could be achieved by including automated and regular timely feedback system for GPs and individual peer and expert clinician support for GPs with regular meetings to discuss recent cases. In addition, trainee support and mentoring to focus on clinical skills, knowledge and risk management issues specific to OOH is currently required. Investigating the stopping rules used for diagnostic closure may provide new insights into the root causes of clinical error in such a high-risk setting.

Functional development in clinical high risk youth: Prediction of schizophrenia versus other psychotic disorders

PubMed Central

Tarbox, Sarah I.; Addington, Jean; Cadenhead, Kristin S.; Cannon, Tyrone D.; Cornblatt, Barbara A.; Perkins, Diana O.; Seidman, Larry J.; Tsuang, Ming T.; Walker, Elaine F.; Heinssen, Robert; McGlashan, Thomas H.; Woods, Scott W.

2013-01-01

This study evaluates premorbid social and academic functioning in clinical high-risk individuals as predictors of transition to schizophrenia versus another psychotic disorder. Participants were 54 individuals enrolled in phase one of the North American Prodrome Longitudinal Study who over two and a half years of follow-up met criteria for schizophrenia/schizophreniform disorder (n = 28) or another psychotic disorder (n = 26). Social and academic functioning in childhood, early adolescence, and late adolescence was assessed at baseline using the Cannon-Spoor Premorbid Adjustment Scale. Social maladjustment in late adolescence predicted significantly higher odds of transition to schizophrenia versus another psychotic disorder independent of childhood and early adolescent adjustment (OR = 4.02) and conveyed unique risk over academic maladjustment (OR = 5.64). Premorbid academic maladjustment was not associated with psychotic disorder diagnosis. Results support diagnostic specificity of premorbid social dysfunction to schizophrenia in clinical high-risk youth and underscore an important role for social maladjustment in the developmental pathology of schizophrenia and its prediction. PMID:24200216

Hopes and Expectations Regarding Genetic Testing for Schizophrenia Among Young Adults at Clinical High-Risk for Psychosis.

PubMed

Friesen, Phoebe; Lawrence, Ryan E; Brucato, Gary; Girgis, Ragy R; Dixon, Lisa

2016-11-01

Genetic tests for schizophrenia could introduce both risks and benefits. Little is known about the hopes and expectations of young adults at clinical high-risk for psychosis concerning genetic testing for schizophrenia, despite the fact that these youth could be among those highly affected by such tests. We conducted semistructured interviews with 15 young adults at clinical high-risk for psychosis to ask about their interest, expectations, and hopes regarding genetic testing for schizophrenia. Most participants reported a high level of interest in genetic testing for schizophrenia, and the majority said they would take such a test immediately if it were available. Some expressed far-reaching expectations for a genetic test, such as predicting symptom severity and the timing of symptom onset. Several assumed that genetic testing would be accompanied by interventions to prevent schizophrenia. Participants anticipated mixed reactions on finding out they had a genetic risk for schizophrenia, suggesting that they might feel both a sense of relief and a sense of hopelessness. We suggest that genetic counseling could play an important role in counteracting a culture of genetic over-optimism and helping young adults at clinical high-risk for psychosis understand the limitations of genetic testing. Counseling sessions could also invite individuals to explore how receiving genetic risk information might impact their well-being, as early evidence suggests that some psychological factors help individuals cope, whereas others heighten distress related to genetic test results.

A combination of clinical balance measures and FRAX® to improve identification of high-risk fallers.

PubMed

Najafi, David A; Dahlberg, Leif E; Hansson, Eva Ekvall

2016-05-03

The FRAX® algorithm quantifies a patient's 10-year probability of a hip or major osteoporotic fracture without taking an individual's balance into account. Balance measures assess the functional ability of an individual and the FRAX® algorithm is a model that integrates the individual patients clinical risk factors [not balance] and bone mineral density. Thus, clinical balance measures capture aspects that the FRAX® algorithm does not, and vice versa. It is therefore possible that combining FRAX® and clinical balance measures can improve the identification of patients at high fall risk and thereby high fracture risk. Our study aim was to explore whether there is an association between clinical balance measures and fracture prediction obtained from FRAX®. A cross-sectional study design was used where post hoc was performed on a dataset of 82 participants (54 to 89 years of age, mean age 71.4, 77 female), with a fall-related wrist-fracture between 2008 and 2012. Balance was measured by tandem stance, standing one leg, walking in the figure of eight, walking heel to toe on a line, walking as fast as possible for 30 m and five times sit to stand balance measures [tandem stance and standing one leg measured first with open and then with closed eyes] and each one analyzed for bivariate relations with the 10-year probability values for hip and major osteoporotic fractures as calculated by FRAX® using Spearman's rank correlation test. Individuals with high FRAX® values had poor outcome in balance measures; however the significance level of the correlation differed between tests. Standing one leg eyes closed had strongest correlation to FRAX® (0.610 p = < 0.01) and Five times sit to stand was the only test that did not correlate with FRAX® (0.013). This study showed that there is an association between clinical balance measures and FRAX®. Hence, the use of clinical balance measures and FRAX® in combination, might improve the identification of individuals with

Correspondence between Psychometric and Clinical High Risk for Psychosis in an Undergraduate Population

PubMed Central

Cicero, David C.; Martin, Elizabeth A.; Becker, Theresa M.; Docherty, Anna; Kerns, John G.

2014-01-01

Despite the common use of either psychometric or clinical methods for identifying individuals at risk for psychosis, previous research has not examined the correspondence and extent of convergence of these two approaches. Undergraduates (n = 160), selected from a larger pool, completed three self-report schizotypy scales, the Magical Ideation Scale, the Perceptual Aberration Scale, and the Revised Social Anhedonia Scale, and were administered the Structured Interview for Prodromal Syndromes (SIPS). First, high correlations were observed for self-report and interview-rated psychotic like experiences (rs between .48 and .61, p < .001). Second, 77 percent of individuals identified as having a risk for psychosis with the self-report measures reported at least one clinically meaningful psychotic-like experience on the SIPS. Third, receiver operating characteristic curve analyses showed that the self-report scales can be used to identify which participants report clinically meaningful positive symptoms. These results suggest that mostly white undergraduate participants identified as at risk with the psychometric schizotypy approach report clinically meaningful psychotic-like experiences in an interview format and that the schizotypy scales are moderately to strongly correlated with interview-rated psychotic-like experiences. The results of the current research provide a baseline for comparing research between these two approaches. PMID:24708081

Sleep disturbances in individuals at clinical high risk for psychosis

PubMed Central

Poe, Sarah-Lucy; Brucato, Gary; Bruno, Nicolina; Arndt, Leigh Y.; Ben-David, Shelly; Gill, Kelly E.; Colibazzi, Tiziano; Kantrowitz, Joshua T.; Corcoran, Cheryl M.; Girgis, Ragy R.

2018-01-01

There has been recent interest in understanding the role that sleep disturbance plays in patients at Clinical High Risk for psychosis (CHR). We assessed sleep disturbance in 194 CHR patients and 66 healthy control subjects and their relationship to symptoms (positive, negative and general functioning). Patients experienced significantly more sleep disturbance than healthy control subjects and their sleep disturbance was related to greater positive and negative symptoms and worse overall functioning. Targeting sleep disturbance in CHR individuals may provide alternative means of treating the CHR syndrome. PMID:28126579

Sleep disturbances in individuals at clinical high risk for psychosis.

PubMed

Poe, Sarah-Lucy; Brucato, Gary; Bruno, Nicolina; Arndt, Leigh Y; Ben-David, Shelly; Gill, Kelly E; Colibazzi, Tiziano; Kantrowitz, Joshua T; Corcoran, Cheryl M; Girgis, Ragy R

2017-03-01

There has been recent interest in understanding the role that sleep disturbance plays in patients at Clinical High Risk for psychosis (CHR). We assessed sleep disturbance in 194 CHR patients and 66 healthy control subjects and their relationship to symptoms (positive, negative and general functioning). Patients experienced significantly more sleep disturbance than healthy control subjects and their sleep disturbance was related to greater positive and negative symptoms and worse overall functioning. Targeting sleep disturbance in CHR individuals may provide alternative means of treating the CHR syndrome. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

Structural Network Disorganization in Subjects at Clinical High Risk for Psychosis.

PubMed

Schmidt, André; Crossley, Nicolas A; Harrisberger, Fabienne; Smieskova, Renata; Lenz, Claudia; Riecher-Rössler, Anita; Lang, Undine E; McGuire, Philip; Fusar-Poli, Paolo; Borgwardt, Stefan

2017-05-01

Previous network studies in chronic schizophrenia patients revealed impaired structural organization of the brain's rich-club members, a set of highly interconnected hub regions that play an important integrative role for global brain communication. Moreover, impaired rich-club connectivity has also been found in unaffected siblings of schizophrenia patients, suggesting that abnormal rich-club connectivity is related to familiar, possibly reflecting genetic, vulnerability for schizophrenia. However, no study has yet investigated whether structural rich-club organization is also impaired in individuals with a clinical risk syndrome for psychosis. Diffusion tensor imaging and probabilistic tractography was used to construct structural whole-brain networks in 24 healthy controls and 24 subjects with an at-risk mental state (ARMS). Graph theory was applied to quantify the structural rich-club organization and global network properties. ARMS subjects revealed a significantly altered structural rich-club organization compared with the control group. The disruption of rich-club organization was associated with the severity of negative psychotic symptoms and led to an elevated level of modularity in ARMS subjects. This study shows that abnormal structural rich-club organization is already evident in clinical high-risk subjects for psychosis and further demonstrates the impact of rich-club disorganization on global network communication. Together with previous evidence in chronic schizophrenia patients and unaffected siblings, our findings suggest that abnormal structural rich-club organization may reflect an endophenotypic marker of psychosis. © The Author 2016. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center.

Insufficient sleep: Enhanced risk-seeking relates to low local sleep intensity.

PubMed

Maric, Angelina; Montvai, Eszter; Werth, Esther; Storz, Matthias; Leemann, Janina; Weissengruber, Sebastian; Ruff, Christian C; Huber, Reto; Poryazova, Rositsa; Baumann, Christian R

2017-09-01

Chronic sleep restriction is highly prevalent in modern society and is, in its clinical form, insufficient sleep syndrome, one of the most prevalent diagnoses in clinical sleep laboratories, with substantial negative impact on health and community burden. It reflects every-day sleep loss better than acute sleep deprivation, but its effects and particularly the underlying mechanisms remain largely unknown for a variety of critical cognitive domains, as, for example, risky decision making. We assessed financial risk-taking behavior after 7 consecutive nights of sleep restriction and after 1 night of acute sleep deprivation compared to a regular sleep condition in a within-subject design. We further investigated potential underlying mechanisms of sleep-loss-induced changes in behavior by high-density electroencephalography recordings during restricted sleep. We show that chronic sleep restriction increases risk-seeking, whereas this was not observed after acute sleep deprivation. This increase was subjectively not noticed and was related to locally lower values of slow-wave energy during preceding sleep, an electrophysiological marker of sleep intensity and restoration, in electrodes over the right prefrontal cortex. This study provides, for the first time, evidence that insufficient sleep restoration over circumscribed cortical areas leads to aberrant behavior. In chronically sleep restricted subjects, low slow-wave sleep intensity over the right prefrontal cortex-which has been shown to be linked to risk behavior-may lead to increased and subjectively unnoticed risk-seeking. Ann Neurol 2017;82:409-418. © 2017 American Neurological Association.

High HIV prevalence among a high-risk subgroup of women attending sexually transmitted infection clinics in Pune, India.

PubMed

Mehta, Shruti H; Gupta, Amita; Sahay, Seema; Godbole, Sheela V; Joshi, Smita N; Reynolds, Steven J; Celentano, David D; Risbud, Arun; Mehendale, Sanjay M; Bollinger, Robert C

2006-01-01

To investigate changes over a decade in prevalence and correlates of HIV among high-risk women attending sexually transmitted infection (STI) clinics in Pune, India, who deny a history of commercial sex work (CSW). Cross-sectional. From 1993 to 2002, 2376 women attending 3 STI clinics in Pune were offered HIV screening. Women who denied CSW were included (n = 1020). Of 1020 women, 21% were HIV infected. The annual HIV prevalence increased from 14% in 1993 to 29% in 2001-2002 (P < 0.001). The change in HIV prevalence over time was paralleled by changes in clinic visitor characteristics; in later periods, women were older, more often employed, less likely to be currently married, and more likely to report condom use. In multivariate analysis, factors independently associated with HIV were calendar period (adjusted odds ratio [AOR], 1.9 for 1997-1999 vs. 1993-1996; 95% CI, 1.2-3.0; AOR, 2.3 for 2000-2002 vs. 1993-1996; 95% CI, 1.5-3.6), lack of formal education (AOR, 2.0; 95% CI, 1.4-2.9), having been widowed (AOR, 3.1; 95% CI, 1.6-6.1), current employment (AOR, 1.8; 95% CI, 1.2-2.6), and genital ulcer disease on examination (AOR, 1.8; 95% CI, 1.2-2.7). Women attending STI clinics in India who deny a history of CSW represent a small, hidden subgroup, likely put at risk for HIV because of high-risk behavior of their male partners, generally their husbands. Educational and awareness efforts that have targeted other subgroups in India (men and CSWs) should also focus on these hard-to-reach women. Risk reduction in this subgroup of Indian women would also be expected to reduce perinatal infections in India.

Disagreement in high-grade/low-grade intraepithelial neoplasia and high-risk/low-risk HPV infection: clinical implications for anal cancer precursor lesions in HIV-positive and HIV-negative MSM.

PubMed

Pimenoff, V N; Félez-Sánchez, M; Tous, S; Clavero, O; Godínez, J M; Klaustermeier, J; Saunier, M; Molijn, A; Alemany, L; Quint, W; Bosch, F X; de Sanjosé, S; McCloskey, J; Bravo, I G

2015-06-01

Anal condylomata are common in HIV-positive individuals and among men who have sex with men (MSM). Generally attributable to infection by low-risk human papillomaviruses (HPVs), condylomata are considered benign low-grade squamous intraepithelial lesions (SILs). However, anal condylomata have occasionally been linked to high-grade SIL and to oncogenic, high-risk HPVs. Here we describe the range of intraepithelial lesions and of the associated HPVs in heterosexual men and women and MSM. Perianal and anal condylomata were collected from 243 patients (56 heterosexual women, 61 heterosexual men and 126 MSM, including 41 HIV-positive MSM). We assessed lesion histology and HPV genotype. Prevalence estimates and Poisson models were used. Irrespective of HIV infection status, MSM showed a higher proportion of condylomata as high-grade SILs compared to heterosexual men/women. High-grade SILs were also more prevalent in anal than in perianal lesions in all patient groups. HIV-positive MSM exhibited increased prevalence ratio (4.6; 95% confidence interval 2.1-10.0) of perianal low-grade SILs containing only high-risk HPVs compared to HIV-negative MSM. In addition, more than 64% of anal SILs with a high-grade component, regardless of HIV infection, were exclusively associated with low-risk HPVs. In anal condylomata, both high-grade and low-grade SILs can be associated with high-risk and/or low-risk HPVs. Particularly, low-grade perianal SILs associated with high-risk HPVs were common in HIV-positive MSM, while presence of only low-risk HPVs in high-grade SILs were common in both MSM groups. Our findings sound a note of caution for the common clinical practice for the treatment of anal condylomata as benign lesions in MSM and HIV-positive patients. Copyright © 2015 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Cannabis use and age at onset of symptoms in subjects at clinical high risk for psychosis.

PubMed

Dragt, S; Nieman, D H; Schultze-Lutter, F; van der Meer, F; Becker, H; de Haan, L; Dingemans, P M; Birchwood, M; Patterson, P; Salokangas, R K R; Heinimaa, M; Heinz, A; Juckel, G; Graf von Reventlow, H; French, P; Stevens, H; Ruhrmann, S; Klosterkötter, J; Linszen, D H

2012-01-01

Numerous studies have found a robust association between cannabis use and the onset of psychosis. Nevertheless, the relationship between cannabis use and the onset of early (or, in retrospect, prodromal) symptoms of psychosis remains unclear. The study focused on investigating the relationship between cannabis use and early and high-risk symptoms in subjects at clinical high risk for psychosis. Prospective multicenter, naturalistic field study with an 18-month follow-up period in 245 help-seeking individuals clinically at high risk. The Composite International Diagnostic Interview was used to assess their cannabis use. Age at onset of high risk or certain early symptoms was assessed retrospectively with the Interview for the Retrospective Assessment of the Onset of Schizophrenia. Younger age at onset of cannabis use or a cannabis use disorder was significantly related to younger age at onset of six symptoms (0.33 < r(s) < 0.83, 0.004 < P < 0.001). Onset of cannabis use preceded symptoms in most participants. Our results provide support that cannabis use plays an important role in the development of psychosis in vulnerable individuals. Cannabis use in early adolescence should be discouraged. © 2011 John Wiley & Sons A/S.

Are HPV vaccination services accessible to high-risk communities? A spatial analysis of HPV-associated cancer and Chlamydia rates and safety-net clinics.

PubMed

Tsui, Jennifer; Rodriguez, Hector P; Gee, Gilbert C; Escobedo, Loraine A; Kominski, Gerald F; Bastani, Roshan

2013-12-01

While HPV vaccines can greatly benefit adolescents and young women from high-risk areas, little is known about whether safety-net immunization services are geographically accessible to communities at greatest risk for HPV-associated diseases. We explore the spatial relationship between areas with high HPV risk and proximity to safety-net clinics from an ecologic perspective. We used cancer registry data and Chlamydia surveillance data to identify neighborhoods within Los Angeles County with high risk for HPV-associated cancers. We examined proximity to safety-net clinics among neighborhoods with the highest risk. Proximity was measured as the shortest distance between each neighborhood center and the nearest clinic and having a clinic within 3 miles of each neighborhood center. The average 5-year non-age-adjusted rates were 1,940 cases per 100,000 for Chlamydia and 60 per 100,000 for HPV-associated cancers. A large majority, 349 of 386 neighborhoods with high HPV-associated cancer rates and 532 of 537 neighborhoods with high Chlamydia rates, had a clinic within 3 miles of the neighborhood center. Clinics were more likely to be located within close proximity to high-risk neighborhoods in the inner city. High-risk neighborhoods outside of this urban core area were less likely to be near accessible clinics. The majority of high-risk neighborhoods were geographically near safety-net clinics with HPV vaccination services. Due to low rates of vaccination, these findings suggest that while services are geographically accessible, additional efforts are needed to improve uptake. Programs aimed to increase awareness about the vaccine and to link underserved groups to vaccination services are warranted.

Are HPV vaccination services accessible to high-risk communities?: A spatial analysis of HPV-associated cancer and Chlamydia rates and safety-net clinics

PubMed Central

Tsui, Jennifer; Rodriguez, Hector P.; Gee, Gilbert C.; Escobedo, Loraine A.; Kominski, Gerald F.; Bastani, Roshan

2013-01-01

Purpose While HPV vaccines can greatly benefit adolescents and young women from high-risk areas, little is known about whether safety-net immunization services are geographically accessible to communities at greatest risk for HPV-associated diseases. We explore the spatial relationship between areas with high HPV risk and proximity to safety-net clinics from an ecologic perspective. Methods We used cancer registry data and Chlamydia surveillance data to identify neighborhoods within Los Angeles County with high risk for HPV-associated cancers. We examined proximity to safety-net clinics among neighborhoods with the highest risk. Proximity was measured as the shortest distance between each neighborhood center and the nearest clinic and having a clinic within 3 miles of each neighborhood center. Results The average 5-year non-age-adjusted rates were 1,940 cases per 100,000 for Chlamydia and 60 per 100,000 for HPV-associated cancers. A large majority, 349 of 386 neighborhoods with high HPV-associated cancer rates and 532 of 537 neighborhoods with high Chlamydia rates had a clinic within 3 miles of the neighborhood center. Clinics were more likely to be located within close proximity to high-risk neighborhoods in the inner city. High-risk neighborhoods outside of this urban core area were less likely to be near accessible clinics. Conclusions The majority of high-risk neighborhoods were geographically near safety-net clinics with HPV vaccination services. Due to low rates of vaccination, these findings suggest that while services are geographically accessible, additional efforts are needed to improve uptake. Programs aimed to increase awareness about the vaccine and to link underserved groups to vaccination services are warranted. PMID:24043448

[Asperger Syndrome and/or Clinical High Risk of Psychosis? A Differential Diagnostic Challenge].

PubMed

Schmidt, Stefanie J; Behar, Ayla; Schultze-Lutter, Frauke

2018-03-01

Asperger Syndrome and/or Clinical High Risk of Psychosis? A Differential Diagnostic Challenge This case-study deals with the often difficult differential diagnosis of Asperger syndrome and a clinical high risk state of psychosis, in particular as indicated by attenuated psychotic symptoms, as well as with its therapeutic implications. The presented case is a 10-year old girl, who has not been diagnosed with an autism spectrum disorder before being referred to a specialized center for early detection of psychosis due to possible hallucinatory experiences and delusional ideas. We demonstrate how to perform a context-sensitive differential diagnosis to distinguish between specific interests as well as related behaviors and unusual thought content as well as perceptive abnormalities, between paranoid ideas and biased interpretations of the behaviors of others typical for autism, and between disorganized symptoms and autistic unusual communication and social behavior. The resulting dual diagnoses in our case-study formed the basis for a complex differential indication, which considered both the increased stress vulnerability associated with an increased risk for the development of psychosis as well as the rigid thinking style associated with autism. Our case-report shows that such a precise differential indication can lead to stabilization over the long-term, even in patients with dual diagnoses.

Reinforcement of high-risk anastomoses using laser-activated protein solders: a clinical study

NASA Astrophysics Data System (ADS)

Libutti, Steven K.; Bessler, Marc; Chabot, J.; Bass, Lawrence S.; Oz, Mehmet C.; Auteri, Joseph S.; Kirsch, Andrew J.; Nowygrod, Roman; Treat, Michael R.

1993-07-01

Anastomotic leakage or breakdown can result in catastrophic complications and significantly increased post-operative morbidity and mortality. Certain anastomoses are subject to a higher incidence of disruption and are therefore termed high risk. In an attempt to decrease the risk of anastomotic leaks, we reinforced sutured anastomoses with a laser activated protein solder in patients undergoing esophagojejunostomies (n equals 2), lung transplantation (n equals 2), and pancreaticojejunostomies (Whipple procedure, n equals 5). The protein solder was composed of 1.0 ml of a 25% human albumin solution, 1.0 ml of sodium hyaluronate, and 0.1 ml of Cardiogreen dye. This composition was applied to the sutured anastomosis and activated with an 860 nm pulsed diode laser. Drains were placed when appropriate and patients were followed for up to 10 months post-operatively and assessed for clinical signs of anastomotic leaks. Results to data demonstrated that there were no immediate complications as a result of the procedure. Operative time was not significantly lengthened. There were no cases of clinically significant leakage from any of the reinforced anastomoses. Laser activated protein solders may help to reduce the incidence of leakage in high risk anastomoses. Large numbers of patients and longer follow-up is needed however, to draw significant conclusions.

Automatic auditory processing deficits in schizophrenia and clinical high-risk patients: forecasting psychosis risk with mismatch negativity.

PubMed

Perez, Veronica B; Woods, Scott W; Roach, Brian J; Ford, Judith M; McGlashan, Thomas H; Srihari, Vinod H; Mathalon, Daniel H

2014-03-15

Only about one third of patients at high risk for psychosis based on current clinical criteria convert to a psychotic disorder within a 2.5-year follow-up period. Targeting clinical high-risk (CHR) individuals for preventive interventions could expose many to unnecessary treatments, underscoring the need to enhance predictive accuracy with nonclinical measures. Candidate measures include event-related potential components with established sensitivity to schizophrenia. Here, we examined the mismatch negativity (MMN) component of the event-related potential elicited automatically by auditory deviance in CHR and early illness schizophrenia (ESZ) patients. We also examined whether MMN predicted subsequent conversion to psychosis in CHR patients. Mismatch negativity to auditory deviants (duration, frequency, and duration + frequency double deviant) was assessed in 44 healthy control subjects, 19 ESZ, and 38 CHR patients. Within CHR patients, 15 converters to psychosis were compared with 16 nonconverters with at least 12 months of clinical follow-up. Hierarchical Cox regression examined the ability of MMN to predict time to psychosis onset in CHR patients. Irrespective of deviant type, MMN was significantly reduced in ESZ and CHR patients relative to healthy control subjects and in CHR converters relative to nonconverters. Mismatch negativity did not significantly differentiate ESZ and CHR patients. The duration + frequency double deviant MMN, but not the single deviant MMNs, significantly predicted the time to psychosis onset in CHR patients. Neurophysiological mechanisms underlying automatic processing of auditory deviance, as reflected by the duration + frequency double deviant MMN, are compromised before psychosis onset and can enhance the prediction of psychosis risk among CHR patients. Copyright © 2014 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.

Can an educational application increase risk perception accuracy amongst patients attending a high-risk breast cancer clinic?

PubMed

Keohane, D; Lehane, E; Rutherford, E; Livingstone, V; Kelly, L; Kaimkhani, S; O'Connell, F; Redmond, H P; Corrigan, M A

2017-04-01

To design, develop and test the effect of an educational initiative to improve risk perception amongst patients attending a high-risk breast cancer clinic. This was achieved through three objectives - 1. identifying an optimal method of presenting risk data, 2. designing and building a risk application, and 3. testing the ability of the application to successfully modify patients perceived risk of cancer. A mobile application was developed for this project using best practice methods for displaying risk information. Patients (n = 84) were randomly allocated into two groups - 'Control' or 'Treatment'. Both groups underwent standard risk counseling while the application was employed in the 'Treatment' group. The patients were surveyed before their session, immediately after and six weeks later. Increases in accuracy were seen in both groups with larger increases demonstrated in the 'Treatment' group with 'Personal 10 Year Risk' statistically significant ('Control' group increase from 21% to 48% vs the 'Treatment' group increase from 33% to 71% - p = 0.003). This project demonstrated trends towards improved risk perception, however mixed logistic regression was unable to show a 30% difference between groups. Numerical literacy and understanding of risk were identified as issues amongst the general population. Overestimating risk remains high amongst attendees. Using mobile applications to convey risk information to patients is a new and evolving area with a corresponding paucity of data. We have demonstrated its potential and emphasised the importance of designing how this information is communicated to patients in order to make it understandable and meaningful. Copyright © 2017 Elsevier Ltd. All rights reserved.

Pharmacology, toxicology, and clinical use of new long acting local anesthetics, ropivacaine and levobupivacaine.

PubMed

Leone, Stefania; Di Cianni, Simone; Casati, Andrea; Fanelli, Guido

2008-08-01

Levobupivacaine and ropivacaine, two new long-acting local anesthetics, have been developed as an alternative to bupivacaine, after the evidence of its severe toxicity. Both of these agents are pure left-isomers and, due to their three-dimensional structure, seem to have less toxic effects on the central nervous system and on the cardiovascular system. Many clinical studies have investigated their toxicology and clinical profiles: theoretically and experimentally, some differences have been observed, but the effects of these properties on clinical practice have not been shown. By examining randomised, controlled trials that have compared these three local agents, this review supports the evidence that both levobupivacaine and ropivacaine have a clinical profile similar to that of racemic bupivacaine, and that the minimal differences reported between the three anesthetics are mainly related to the slightly different anesthetic potency, with racemic bupivacaine > levobupivacaine > ropivacaine. However, the reduced toxic potential of the two pure left-isomers suggests their use in the clinical situations in which the risk of systemic toxicity related to either overdosing or unintended intravascular injection is high, such as during epidural or peripheral nerve blocks.

Effect of RAAS blockers on adverse clinical outcomes in high CVD risk subjects with atrial fibrillation

PubMed Central

Chaugai, Sandip; Sherpa, Lhamo Yanchang; Sepehry, Amir A.; Arima, Hisatomi; Wang, Dao Wen

2016-01-01

Abstract Recent studies have demonstrated that atrial fibrillation significantly increases the risk of adverse clinical outcomes in high cardiovascular disease risk subjects. Application of renin–angiotensin–aldosterone system blockers for prevention of recurrence of atrial fibrillation and adverse clinical outcomes in subjects with atrial fibrillation is a theoretically appealing concept. However, results of clinical trials evaluating the effect of renin–angiotensin–aldosterone blockers on adverse clinical outcomes in high cardiovascular disease risk subjects with atrial fibrillation remain inconclusive. A pooled study of 6 randomized controlled trials assessing the efficacy of renin–angiotensin–aldosterone blockers on subjects with atrial fibrillation was performed. A total of 6 randomized controlled trials enrolled a total of 53,510 patients followed for 1 to 5 years. RAAS blockade therapy was associated with 14% reduction in the incidence of heart failure (OR: 0.86, [95%CI: 0.76– 0.97], P=0.018) and 17% reduction in the incidence of CVE (OR: 0.83, [95%CI: 0.70–0.99], P = 0.038). The corresponding decline in absolute risk against heart failure (ARR: 1.4%, [95%CI: 0.2–2.6%], P = 0.018) and CVE (ARR: 3.5%, [95%CI: 0.0–6.9%], P = 0.045) in the AF group was much higher than the non-AF group for heart failure (ARR: 0.4%, [95%CI: 0.0–0.7%], P = 0.057) and CVE (ARR: 1.6%, [95%CI: –0.1% to 3.3%], P = 0.071). No significant effect was noted on all-cause or cardiovascular mortality, stroke, or myocardial infarction. This study suggests that RAAS blockade offers protection against heart failure and cardiovascular events in high cardiovascular disease risk subjects with atrial fibrillation. PMID:27368043

Contemporary Population-Based Comparison of Localized Ductal Adenocarcinoma and High-Risk Acinar Adenocarcinoma of the Prostate.

PubMed

Packiam, Vignesh T; Patel, Sanjay G; Pariser, Joseph J; Richards, Kyle A; Weiner, Adam B; Paner, Gladell P; VanderWeele, David J; Zagaja, Gregory P; Eggener, Scott E

2015-10-01

To compare pathological characteristics, treatment patterns, and survival in patients with ductal adenocarcinoma (DC) compared to those with acinar adenocarcinoma (AC). Using the National Cancer Database, we identified patients diagnosed with clinically localized (cN0, cM0) pure DC (n = 1328) and AC (n = 751,635) between 1998 and 2011. High-risk AC was defined as Gleason 8-10. Demographic, treatment, pathological, and survival characteristics of patients were compared. Compared to patients with Gleason 8-10 AC, those with DC presented with lower mean prostate-specific antigen (10.3 vs 16.2 ng/mL, P <.001), had similar rates (11.7% vs 11.5%, P = .8) of clinical extra-capsular extension (stage ≥ cT3), and were more likely to undergo prostatectomy (54% vs 36%, P <.001). Compared to patients with Gleason 8-10 AC undergoing prostatectomy, those with DC had more favorable pathology: stage ≥ T3 (39% vs 52%, P <.001), fewer positive lymph nodes (4% vs 11%, P <.001), and fewer positive margins (25% vs 33%, P <.001). On Kaplan-Meier analysis, patients with DC had similar 5-year survival (75.0%, 95% confidence interval [CI] [71.7-78.9]) compared to those with Gleason 8-10 AC (77.1%, 95% CI [76.6%-77.6%], P = .2). On Cox multivariable analysis, patients with Gleason 8-10 AC had a similar risk of death compared to those with DC (hazards ratio = 0.92, 95% CI [0.69-1.23], P = 6). In this large contemporary population-based series, patients with DC of the prostate presented with lower prostate-specific antigen, had more favorable pathological features, and similar overall survival compared to men with Gleason 8-10 AC. Copyright © 2015 Elsevier Inc. All rights reserved.

Adaptation of clinical prediction models for application in local settings.

PubMed

Kappen, Teus H; Vergouwe, Yvonne; van Klei, Wilton A; van Wolfswinkel, Leo; Kalkman, Cor J; Moons, Karel G M

2012-01-01

When planning to use a validated prediction model in new patients, adequate performance is not guaranteed. For example, changes in clinical practice over time or a different case mix than the original validation population may result in inaccurate risk predictions. To demonstrate how clinical information can direct updating a prediction model and development of a strategy for handling missing predictor values in clinical practice. A previously derived and validated prediction model for postoperative nausea and vomiting was updated using a data set of 1847 patients. The update consisted of 1) changing the definition of an existing predictor, 2) reestimating the regression coefficient of a predictor, and 3) adding a new predictor to the model. The updated model was then validated in a new series of 3822 patients. Furthermore, several imputation models were considered to handle real-time missing values, so that possible missing predictor values could be anticipated during actual model use. Differences in clinical practice between our local population and the original derivation population guided the update strategy of the prediction model. The predictive accuracy of the updated model was better (c statistic, 0.68; calibration slope, 1.0) than the original model (c statistic, 0.62; calibration slope, 0.57). Inclusion of logistical variables in the imputation models, besides observed patient characteristics, contributed to a strategy to deal with missing predictor values at the time of risk calculation. Extensive knowledge of local, clinical processes provides crucial information to guide the process of adapting a prediction model to new clinical practices.

The relationship of social function to depressive and negative symptoms in individuals at clinical high risk for psychosis.

PubMed

Corcoran, C M; Kimhy, D; Parrilla-Escobar, M A; Cressman, V L; Stanford, A D; Thompson, J; David, S Ben; Crumbley, A; Schobel, S; Moore, H; Malaspina, D

2011-02-01

Social dysfunction is a hallmark symptom of schizophrenia which commonly precedes the onset of psychosis. It is unclear if social symptoms in clinical high-risk patients reflect depressive symptoms or are a manifestation of negative symptoms. We compared social function scores on the Social Adjustment Scale-Self Report between 56 young people (aged 13-27 years) at clinical high risk for psychosis and 22 healthy controls. The cases were also assessed for depressive and 'prodromal' symptoms (subthreshold positive, negative, disorganized and general symptoms). Poor social function was related to both depressive and negative symptoms, as well as to disorganized and general symptoms. The symptoms were highly intercorrelated but linear regression analysis demonstrated that poor social function was primarily explained by negative symptoms within this cohort, particularly in ethnic minority patients. Although this study demonstrated a relationship between social dysfunction and depressive symptoms in clinical high-risk cases, this association was primarily explained by the relationship of each of these to negative symptoms. In individuals at heightened risk for psychosis, affective changes may be related to a progressive decrease in social interaction and loss of reinforcement of social behaviors. These findings have relevance for potential treatment strategies for social dysfunction in schizophrenia and its risk states and predict that antidepressant drugs, cognitive behavioral therapy and/or social skills training may be effective.

Favorable Local Control From Consolidative Radiation Therapy in High-Risk Neuroblastoma Despite Gross Residual Disease, Positive Margins, or Nodal Involvement

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ferris, Matthew J., E-mail: mjferri@emory.edu; Winship Cancer Institute, Emory University, Atlanta, Georgia; Danish, Hasan

Purpose: To report the influence of radiation therapy (RT) dose and surgical pathology variables on disease control and overall survival (OS) in patients treated for high-risk neuroblastoma at a single institution. Methods and Materials: We conducted a retrospective study of 67 high-risk neuroblastoma patients who received RT as part of definitive management from January 2003 until May 2014. Results: At a median follow-up of 4.5 years, 26 patients (38.8%) failed distantly; 4 of these patients also failed locally. One patient progressed locally without distant failure. Local control was 92.5%, and total disease control was 59.5%. No benefit was demonstrated for RT doses over 21.6 Gymore » with respect to local relapse–free survival (P=.55), disease-free survival (P=.22), or OS (P=.72). With respect to local relapse–free survival, disease-free survival, and OS, no disadvantage was seen for positive lymph nodes on surgical pathology, positive surgical margins, or gross residual disease. Of the patients with gross residual disease, 75% (6 of 8) went on to have no evidence of disease at time of last follow-up, and the 2 patients who failed did so distantly. Conclusions: Patients with high-risk neuroblastoma in this series maintained excellent local control, with no benefit demonstrated for radiation doses over 21.6 Gy, and no disadvantage demonstrated for gross residual disease after surgery, positive surgical margins, or pathologic lymph node positivity. Though the limitations of a retrospective review for an uncommon disease must be kept in mind, with small numbers in some of the subgroups, it seems that dose escalation should be considered only in exceptional circumstances.« less

Understanding Local Policy Elites' Perceptions on the Benefits and Risks Associated with High-Voltage Power Line Installations in the State of Arkansas.

PubMed

Moyer, Rachael M; Song, Geoboo

2016-10-01

Recently, a controversial policy debate has arisen concerning the installation of high-voltage power lines in northwest Arkansas. While proponents argue that such an installation is inevitable to efficiently and reliably support the identified electric load in the region, opponents claim that the lines will degrade the natural environment and hamper the tourism-based local economy in affected regions, notably in Ozark Mountain areas. Of particular interest is to understand how local policy elites perceive the benefits and risks associated with such divisive proposals, which is critical for comprehending the formation and changes of related government policies. Based upon the dual process theory of judgment, this study systematically investigates the triadic relationships between (a) more profound personal value predispositions, (b) affects and feelings, and (c) perceived benefits and risks related to the proposed installation of high-voltage power lines among local policy elites in the state of Arkansas. In doing so, we analyze original data collected from a statewide Internet survey of 420 local leaders and key policymakers about their opinions on the related issues, while considering other factors claimed by previous literature to influence risk perceptions, including trust, knowledge level, and demographic characteristics. Analytical results suggest that grid-group cultural predispositions, as deeply held core values within local policy elites' individual belief systems, both directly and indirectly-through affective feelings-shape perceived utility associated with the installation of high-voltage power lines. We conclude this article by suggesting some practical considerations for better designing policy addressing controversial issues of this nature. © 2016 Society for Risk Analysis.

Clinical nursing leaders', team members' and service managers' experiences of implementing evidence at a local level.

PubMed

Kitson, Alison; Silverston, Heidi; Wiechula, Rick; Zeitz, Kathryn; Marcoionni, Danni; Page, Tammy

2011-05-01

To describe the experiences of 14 clinical nursing leaders introducing a knowledge translation (KT) project into one metropolitan acute care hospital in South Australia. The study also explored team members' and service managers' experiences. KT strategies assume that local (nursing) clinical leaders have the capacity and capability to champion innovation combining positional leadership roles (ward leader) with a project lead role. There is limited evidence to support these assumptions. Semi-structured interviews of clinical nursing leaders and managers were undertaken at month 4 and 12 of the project. Data were also collected from the interdisciplinary team members (n = 28). Clinical nursing leaders identified risks and anxieties associated with taking on an additional leadership role, whereas managers acknowledged the multiple pressures on the system and the need for local level innovation. Team members generally reported positive experiences. With support, clinical nursing leaders can effectively embrace KT project leadership roles that complement their positional leadership roles. Clinical nursing leaders' experiences differed from nursing and medical managers' experiences.   Managers need to be more attuned to the personal risks local leaders experience, providing support for leaders to experiment and innovate. Managers need to integrate local priorities with broader system wide agendas. © 2011 The Authors. Journal compilation © 2011 Blackwell Publishing Ltd.

Clinical high risk for psychosis in children and adolescents: a systematic review.

PubMed

Tor, Jordina; Dolz, Montserrat; Sintes, Anna; Muñoz, Daniel; Pardo, Marta; de la Serna, Elena; Puig, Olga; Sugranyes, Gisela; Baeza, Inmaculada

2017-09-15

The concept of being at risk for psychosis has been introduced both for adults and children and adolescents, but fewer studies have been conducted in the latter population. The aim of this study is to systematically review the articles associated with clinical description, interventions, outcome and other areas in children and adolescents at risk for psychosis. We searched in MEDLINE/PubMed and PsycINFO databases for articles published up to 30/06/16. Reviewed articles were prospective studies; written in English; original articles with Clinical High Risk (CHR) for psychosis samples; and mean age of samples younger than 18 years. From 103 studies initially selected, 48 met inclusion criteria and were systematically reviewed. Studies show that CHR children and adolescents present several clinical characteristics at baseline, with most attenuated positive-symptom inclusion criteria observed, reporting mostly perceptual abnormalities and suspiciousness, and presenting comorbid conditions such as depressive and anxiety disorders. CHR children and adolescents show lower general intelligence and no structural brain changes compared with controls. Original articles reviewed show rates of conversion to psychosis between 17 and 20% at 1 year follow-up and between 7 and 21% at 2 years. While 36% of patients recovered from their CHR status at 6-year follow-up, 40% still met CHR criteria. Studies in children and adolescents with CHR were conducted with different methodologies, assessments tools and small samples. It is important to conduct studies on psychopharmacological and psychological treatment, as well as replication of the few studies found.

Using 'WeChat' online social networking in a real-world needs analysis of family members of youths at clinical high risk of psychosis.

PubMed

Zhang, TianHong; Xu, LiHua; Tang, YingYing; Cui, HuiRu; Li, HuiJun; Wei, YanYan; Xu, YangYang; Jiang, LiJuan; Zhu, YiKang; Li, ChunBo; Jiang, KaiDa; Xiao, ZePing; Wang, JiJun

2018-04-01

The argument surrounding the safety and effectiveness of interventions for the population of individuals at a clinical high risk of developing psychosis has been ongoing for the past 30 years. However, few studies have assessed the needs of this special young population, who are struggling with the recent onset of psychotic symptoms. The sample consisted of 171 family members of 108 clinical high-risk individuals included from the ShangHai at Risk for Psychosis research programme. A 'WeChat' group was established to provide mutual support. There were 22,007 valid messages sent within the group between 1 April 2015 and 27 June 2016. Chat records were subsequently analysed to determine the needs of families during intervention at the early stages of psychosis. Families of clinical high-risk individuals were highly involved in the entire medical process, and the major concerns of the families of clinical high-risk individuals focused on both functional recovery and medication. The themes of 'take medication', 'go to school' and 'study in school' were often discussed within the group. A family-focused intervention targeting functional recovery and real-time professional explanations of medication would meet the major needs of families of Chinese clinical high-risk individuals.

The Recidivism Patterns of Previously Deported Aliens Released from a Local Jail: Are They High-Risk Offenders?

ERIC Educational Resources Information Center

Hickman, Laura J.; Suttorp, Marika J.

2010-01-01

Previously deported aliens are a group about which numerous claims are made but very few facts are known. Using data on male deportable aliens released from a local jail, the study sought to test the ubiquitous claim that they pose a high risk of recidivism. Using multiple measures of recidivism and propensity score weighting to account for…

Clinical risk management.

PubMed

Knowles, D

Managing clinical risk involves all staff with clinical and managerial responsibilities. This article draws attention to some key steps in risk management and ways to deal with the problems when things do go wrong.

Clinical significance of MYCN amplification in patients with high-risk neuroblastoma.

PubMed

Lee, Ji Won; Son, Meong Hi; Cho, Hee Won; Ma, Young Eun; Yoo, Keon Hee; Sung, Ki Woong; Koo, Hong Hoe

2018-05-24

This study investigated the clinical significance of MYCN amplification within high-risk neuroblastoma (NB). Medical records of 135 patients who were diagnosed with high-risk NB from 2004 to 2016 were reviewed. Fifty-one (38%) patients had MYCN amplified tumors, and the remaining 84 (62%) had nonamplified tumors. MYCN amplification was associated with abdominal primary site, less differentiated pathology, higher levels of lactate dehydrogenase and neuron-specific enolase (NSE), lower vanillylmandelic acid level, and larger primary tumor volume at diagnosis. MYCN amplification was associated with a better early response (faster reduction of primary tumor volume and NSE level). The proportion of patients in complete response or very good partial response after induction treatment was relatively higher in MYCN amplified tumors than in nonamplified tumors; however, all progressions during induction treatment occurred only in MYCN amplified tumors (P = 0.007). The time to progression was shorter (median 1.5 years vs. 1.9 years, P = 0.037) and survival after relapse/progression was worse in MYCN amplified tumors (3 year overall survival: 7.7 ± 7.4% vs. 20.5 ± 8.8%, P = 0.046). There was no difference in event-free survival and overall survival between MYCN amplified and nonamplified tumors. MYCN amplification was associated with more aggressive features at diagnosis and a better early response, but a higher progression rate during induction treatment and lower chance of survival after relapse/progression. There was no difference in survival rates according to MYCN amplification in patients with high-risk NB. © 2018 Wiley Periodicals, Inc.

Development and Validation of a Clinic-Based Prediction Tool to Identify Female Athletes at High Risk for Anterior Cruciate Ligament Injury

PubMed Central

Myer, Gregory D.; Ford, Kevin R.; Khoury, Jane; Succop, Paul; Hewett, Timothy E.

2012-01-01

Background Prospective measures of high knee abduction moment (KAM) during landing identify female athletes at high risk for anterior cruciate ligament injury. Laboratory-based measurements demonstrate 90% accuracy in prediction of high KAM. Clinic-based prediction algorithms that employ correlates derived from laboratory-based measurements also demonstrate high accuracy for prediction of high KAM mechanics during landing. Hypotheses Clinic-based measures derived from highly predictive laboratory-based models are valid for the accurate prediction of high KAM status, and simultaneous measurements using laboratory-based and clinic-based techniques highly correlate. Study Design Cohort study (diagnosis); Level of evidence, 2. Methods One hundred female athletes (basketball, soccer, volleyball players) were tested using laboratory-based measures to confirm the validity of identified laboratory-based correlate variables to clinic-based measures included in a prediction algorithm to determine high KAM status. To analyze selected clinic-based surrogate predictors, another cohort of 20 female athletes was simultaneously tested with both clinic-based and laboratory-based measures. Results The prediction model (odds ratio: 95% confidence interval), derived from laboratory-based surrogates including (1) knee valgus motion (1.59: 1.17-2.16 cm), (2) knee flexion range of motion (0.94: 0.89°-1.00°), (3) body mass (0.98: 0.94-1.03 kg), (4) tibia length (1.55: 1.20-2.07 cm), and (5) quadriceps-to-hamstrings ratio (1.70: 0.48%-6.0%), predicted high KAM status with 84% sensitivity and 67% specificity (P < .001). Clinic-based techniques that used a calibrated physician’s scale, a standard measuring tape, standard camcorder, ImageJ software, and an isokinetic dynamometer showed high correlation (knee valgus motion, r = .87; knee flexion range of motion, r = .95; and tibia length, r = .98) to simultaneous laboratory-based measurements. Body mass and quadriceps-to-hamstrings ratio

Cyberbullying in those at clinical high risk for psychosis.

PubMed

Magaud, Emilie; Nyman, Karissa; Addington, Jean

2013-11-01

Several studies suggest an association between experiences of childhood trauma including bullying and the development of psychotic symptoms. The use of communications technology has created a new media for bullying called 'cyberbullying'. Research has demonstrated associations between traditional bullying and cyberbullying. Negative effects of cyberbullying appear similar in nature and severity to the reported effects of traditional bullying. Our aim was to examine the prevalence and correlates of cyberbullying in those at clinical high risk (CHR) for psychosis. Fifty young people at CHR for psychosis were administered the Childhood Trauma Questionnaire with added questions about cyberbullying. Cyberbullying was reported in 38% of the sample. Those who experienced cyberbullying also reported experiencing previous trauma. It is possible that cyberbullying may be a problem for those at CHR of psychosis, and due to the vulnerable nature of these young people may have longitudinal implications. © 2013 Wiley Publishing Asia Pty Ltd.

A clinical algorithm identifies high risk pediatric oncology and bone marrow transplant patients likely to benefit from treatment of adenoviral infection.

PubMed

Williams, Kirsten Marie; Agwu, Allison L; Dabb, Alix A; Higman, Meghan A; Loeb, David M; Valsamakis, Alexandra; Chen, Allen R

2009-11-01

Adenoviral infections cause morbidity and mortality in blood and marrow transplantation and pediatric oncology patients. Cidofovir is active against adenovirus, but must be used judiciously because of its nephrotoxicity and unclear indications. Therefore, before introducing cidofovir use during an adenoviral outbreak, we developed a clinical algorithm to distinguish low risk patients from those who merited cidofovir therapy because of significant adenoviral disease and high risk for death. This study was conducted to determine whether the algorithm accurately predicted severe adenovirus disease and whether selective cidofovir treatment was beneficial. A retrospective analysis of a pediatric oncology/blood and marrow transplantation cohort prealgorithm and postalgorithm implementation was performed. Twenty patients with adenovirus infection were identified (14 high risk and 6 low risk). All low-risk patients cleared their infections without treatment. Before algorithm implementation, all untreated high-risk patients died, 4 out of 5 (80%), from adenoviral infection. In contrast, cidofovir reduced adenovirus-related mortality in the high-risk group postalgorithm implementation (9 patients treated, 1 patient died; RR 0.14, P<0.05) and all treated high-risk patients cleared their virus. The clinical algorithm accurately identified patients at high risk for severe fatal adenoviral disease who would benefit from selective use of cidofovir.

Neuroanatomical and Symptomatic Sex Differences in Individuals at Clinical High Risk for Psychosis.

PubMed

Guma, Elisa; Devenyi, Gabriel A; Malla, Ashok; Shah, Jai; Chakravarty, M Mallar; Pruessner, Marita

2017-01-01

Sex differences have been widely observed in clinical presentation, functional outcome and neuroanatomy in individuals with a first-episode of psychosis, and chronic patients suffering from schizophrenia. However, little is known about sex differences in the high-risk stages for psychosis. The present study investigated sex differences in cortical and subcortical neuroanatomy in individuals at clinical high risk (CHR) for psychosis and healthy controls (CTL), and the relationship between anatomy and clinical symptoms in males at CHR. Magnetic resonance images were collected in 26 individuals at CHR (13 men) and 29 CTLs (15 men) to determine total and regional brain volumes and morphology, cortical thickness, and surface area (SA). Clinical symptoms were assessed with the brief psychiatric rating scale. Significant sex-by-diagnosis interactions were observed with opposite directions of effect in male and female CHR subjects relative to their same-sex controls in multiple cortical and subcortical areas. The right postcentral, left superior parietal, inferior parietal supramarginal, and angular gyri [<5% false discovery rate (FDR)] were thicker in male and thinner in female CHR subjects compared with their same-sex CTLs. The same pattern was observed in the right superior parietal gyrus SA at the regional and vertex level. Using a recently developed surface-based morphology pipeline, we observed sex-specific shape differences in the left hippocampus (<5% FDR) and amygdala (<10% FDR). Negative symptom burden was significantly higher in male compared with female CHR subjects ( p  = 0.04) and was positively associated with areal expansion of the left amygdala in males (<5% FDR). Some limitations of the study include the sample size, and data acquisition at 1.5 T. This study demonstrates neuroanatomical sex differences in CHR subjects, which may be associated with variations in symptomatology in men and women with psychotic symptoms.

Clinical and economic effectiveness of percutaneous ventricular assist devices for high-risk patients undergoing percutaneous coronary intervention.

PubMed

Shah, Atman P; Retzer, Elizabeth M; Nathan, Sandeep; Paul, Jonathan D; Friant, Janet; Dill, Karin E; Thomas, Joseph L

2015-03-01

Comparative effectiveness research (CER) is taking a more prominent role in formalizing hospital treatment protocols and health-care coverage policies by having health-care providers consider the impact of new devices on costs and outcomes. CER balances the need for innovation with fiscal responsibility and evidence-based care. This study compared the clinical and economic impact of percutaneous ventricular assist devices (pVAD) with intraaortic balloon pumps for high-risk patients undergoing percutaneous coronary intervention (PCI). This study conducted a review of all comparative randomized control trials of the pVADS (Impella and TandemHeart) vs IABP for patients undergoing high-risk percutaneous coronary intervention (PCI). A retrospective analysis of the 2010 and 2011 Medicare MEDPAR data files was also performed to compare procedural costs and hospital length of stay (LOS). Readmission rates between the devices were also studied. Based on available trials, there is no significant clinical benefit with pVAD compared to IABP. Use of pVADs is associated with increased length of Intensive Care Unit stay and a total longer LOS. The incremental budget impact for pVADs was $33,957,839 for the United States hospital system (2010-2011). pVADs are not associated with improved clinical outcomes, reduced hospital length of stay, or reduced readmission rates. Management of high-risk PCI and cardiogenic shock patients with IABP is more cost effective than a routine use of pVADS. Use of IABP as initial therapy in high-risk PCI and cardiogenic shock patients may result in savings of up to $2.5 billion annually of incremental costs to the hospital system.

Clinically Enhancing Local Anesthesia Techniques for Endodontic Treatment.

PubMed

Bahcall, James; Xie, Qian

2017-02-01

Local anesthesia is one of the most important drugs given to patients who undergo endodontic treatment. Yet, clinicians often do not view local anesthetic agents as drugs and, therefore, struggle clinically to consistently achieve profound pulpal anesthesia. To improve the clinical effects of local anesthesia for endodontic treatment, in conjunction with selecting the correct type of local anesthesia, clinicians need to thoroughly understand how the local anesthetic process works and how to objectively test for clinical signs of pulpal anesthesia and integrate supplemental anesthesia when appropriate.

High-Dose-Rate Interstitial Brachytherapy as Monotherapy for Clinically Localized Prostate Cancer: Treatment Evolution and Mature Results

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zamboglou, Nikolaos; Tselis, Nikolaos, E-mail: ntselis@hotmail.com; Baltas, Dimos

2013-03-01

Purpose: To report the clinical outcome of high-dose-rate (HDR) interstitial (IRT) brachytherapy (BRT) as sole treatment (monotherapy) for clinically localized prostate cancer. Methods and Materials: Between January 2002 and December 2009, 718 consecutive patients with clinically localized prostate cancer were treated with transrectal ultrasound (TRUS)-guided HDR monotherapy. Three treatment protocols were applied; 141 patients received 38.0 Gy using one implant in 4 fractions of 9.5 Gy with computed tomography-based treatment planning; 351 patients received 38.0 Gy in 4 fractions of 9.5 Gy, using 2 implants (2 weeks apart) and intraoperative TRUS real-time treatment planning; and 226 patients received 34.5 Gy,more » using 3 single-fraction implants of 11.5 Gy (3 weeks apart) and intraoperative TRUS real-time treatment planning. Biochemical failure was defined according to the Phoenix consensus, and toxicity was evaluated using Common Toxicity Criteria for Adverse Events version 3. Results: The median follow-up time was 52.8 months. The 36-, 60-, and 96-month biochemical control and metastasis-free survival rates for the entire cohort were 97%, 94%, and 90% and 99%, 98%, and 97%, respectively. Toxicity was scored per event, with 5.4% acute grade 3 genitourinary and 0.2% acute grade 3 gastrointestinal toxicity. Late grade 3 genitourinary and gastrointestinal toxicities were 3.5% and 1.6%, respectively. Two patients developed grade 4 incontinence. No other instance of grade 4 or greater acute or late toxicity was reported. Conclusion: Our results confirm IRT-HDR-BRT is safe and effective as monotherapy for clinically localized prostate cancer.« less

Clinical and psychological telemonitoring and telecare of high risk heart failure patients.

PubMed

Villani, Alessandra; Malfatto, Gabriella; Compare, Angelo; Della Rosa, Francesco; Bellardita, Lara; Branzi, Giovanna; Molinari, Enrico; Parati, Gianfranco

2014-12-01

We conducted a trial of telemonitoring and telecare for patients with chronic heart failure leaving hospital after being treated for clinical instability. Eighty patients were randomized before hospital discharge to a usual care group (n=40: follow-up at the outpatient clinic) or to an integrated management group (n=40: patients learned to use a handheld PDA and kept in touch daily with the monitoring centre). At enrolment, the groups were similar for all clinical variables. At one-year follow-up, integrated management patients showed better adherence, reduced anxiety and depression, and lower NYHA class and plasma levels of BNP with respect to the usual care patients (e.g. NYHA class 2.1 vs 2.4, P<0.02). Mortality and hospital re-admissions for congestive heart failure were also reduced in integrated management patients (P<0.05). Integrated management was more expensive than usual care, although the cost of adverse events was 42% lower. In heart failure patients at high risk of relapse, the regular acquisition of simple clinical information and the possibility for the patient to contact the clinical staff improved drug titration, produced better psychological status and quality of life, and reduced hospitalizations for heart failure. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Characterization of HIV Recent Infection Among High-Risk Men at Public STI Clinics in Mumbai.

PubMed

Truong, Hong-Ha M; Fatch, Robin; Grant, Robert M; Mathur, Meenakshi; Kumta, Sameer; Jerajani, Hemangi; Kellogg, Timothy A; Lindan, Christina P

2018-02-16

We examined associations with HIV recent infection and estimated transmitted drug resistance (TDR) prevalence among 3345 men at sexually transmitted infection clinics in Mumbai (2002-2005). HIV seroincidence was 7.92% by the BED-CEIA and was higher at a clinic located near brothels (12.39%) than at a hospital-based clinic (3.94%). HIV recent infection was associated with a lifetime history of female sex worker (FSW) partners, HSV-2, genital warts, and gonorrhea. TDR prevalence among recent infection cases was 5.7%. HIV testing services near sex venues may enhance case detection among high-risk men who represent a bridging population between FSWs and the men's other sexual partners.

Predicting the onset of psychosis in patients at clinical high risk: practical guide to probabilistic prognostic reasoning.

PubMed

Fusar-Poli, P; Schultze-Lutter, F

2016-02-01

Prediction of psychosis in patients at clinical high risk (CHR) has become a mainstream focus of clinical and research interest worldwide. When using CHR instruments for clinical purposes, the predicted outcome is but only a probability; and, consequently, any therapeutic action following the assessment is based on probabilistic prognostic reasoning. Yet, probabilistic reasoning makes considerable demands on the clinicians. We provide here a scholarly practical guide summarising the key concepts to support clinicians with probabilistic prognostic reasoning in the CHR state. We review risk or cumulative incidence of psychosis in, person-time rate of psychosis, Kaplan-Meier estimates of psychosis risk, measures of prognostic accuracy, sensitivity and specificity in receiver operator characteristic curves, positive and negative predictive values, Bayes' theorem, likelihood ratios, potentials and limits of real-life applications of prognostic probabilistic reasoning in the CHR state. Understanding basic measures used for prognostic probabilistic reasoning is a prerequisite for successfully implementing the early detection and prevention of psychosis in clinical practice. Future refinement of these measures for CHR patients may actually influence risk management, especially as regards initiating or withholding treatment. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Consumption of a high-fat, high-calorie meal is associated with an increase in intracellular co-localization of PPAR-γ mRNA and protein in monocytes.

PubMed

Henning, Andrea L; McFarlin, Brian K

2017-01-01

Acute and habitual dietary habits contribute to the onset and progression of many forms of cardiovascular disease. Circulating peripheral blood monocytes have been a target of pre-clinical research related to the risk of atherosclerosis. Specifically, when monocytes migrate into the subendothelial space and endocytosize modified LDL (i.e. acLDL or oxLDL) they phenotypically transform into foam cells. The endocytosis of modified LDL is mediated by the scavenger receptor CD36, whose expression is in tern regulated by the transcription factor PPAR-γ. In this report, we describe a novel technique for the simultaneous measurement of intracellular PPAR-γ mRNA and protein in peripheral blood monocytes collected from human subjects in fasted state or 3 and 5-h after consuming a high-calorie (65% of daily calorie needs), high-fat meal. Intracellular detection and co-localization of PPAR-γ was made possible using a combination of image-based flow cytometry (MilliporeSigma FlowSight) and an amplified mRNA FISH staining technique (Affymetrix/eBioscience PrimeFlow). Consumption of a high-calorie, high-fat meal increased the percentage of co-localization at both 3 and 5-h post prandial compared to pre-meal. No obvious difference in co-localization was observed when cells were treated by acLDL in vitro. More research is needed to determine how to best use this method to study pre-clinical risk of atherosclerosis. Copyright © 2016. Published by Elsevier Inc.

A Virtual Clinic Improves Pneumococcal Vaccination for Asplenic Veterans at High Risk for Pneumococcal Disease

PubMed Central

Jump, Robin L.; Banks, Richard; Wilson, Brigid; Montpetite, Michelle M.; Carter, Rebecca; Phillips, Susan; Perez, Federico

2015-01-01

We developed a “virtual clinic” to improve pneumococcal vaccination among asplenic adults. Using an electronic medical record, we identified patients, assessed their vaccination status, entered orders, and notified patients and providers. Within 180 days, 38 of 76 patients (50%) received a pneumococcal vaccination. A virtual clinic may optimize vaccinations among high-risk patients. PMID:26668815

Exemestane Reduces Breast Cancer Risk in High-Risk Postmenopausal Women

Cancer.gov

Clinical trial results presented at the 2011 ASCO annual meeting showed that the aromatase inhibitor exemestane—used to treat early and advanced breast cancer—substantially reduced the risk of invasive breast cancer in high-risk postmenopausal women.

Angio-Architectural Features of High-Grade Intracranial Dural Arteriovenous Fistulas: Correlation With Aggressive Clinical Presentation and Hemorrhagic Risk.

PubMed

Della Pepa, Giuseppe Maria; Parente, Paolo; D'Argento, Francesco; Pedicelli, Alessandro; Sturiale, Carmelo Lucio; Sabatino, Giovanni; Albanese, Alessio; Puca, Alfredo; Fernandez, Eduardo; Olivi, Alessando; Marchese, Enrico

2017-08-01

High-grade dural arteriovenous fistulas (dAVFs) can present shunts with very different angio-architectural characteristics. Specific hemodynamic factors may affect clinical history and determine very different clinical courses. To evaluate the relationship between some venous angio-architectural features in high-grade dAVFs and clinical presentation. Specific indicators of moderate or severe venous hypertension were analyzed, such as altered configurations of the dural sinuses (by a single or a dual thrombosis), or overload of cortical vessels (restrictions of outflow, pseudophlebitic cortical vessels, and venous aneurysms). The institutional series was retrospectively reviewed (49 cases), and the pattern of venous drainage was analyzed in relationship with clinical presentation (benign/aggressive/hemorrhage). Thirty-five of 49 cases displayed cortical reflux (high-grade dAVFs). This subgroup displayed a benign presentation in 31.42% of cases, an aggressive in 31.42%, and hemorrhage in 37.14%. Our data confirm that within high-grade dAVFs, 2 distinct subpopulations exist according to severity of clinical presentation. Some indicators we examined showed correlation with aggressive nonhemorrhagic manifestations (outflow restriction and pseudophlebitic cortical vessels), while other showed a correlation with hemorrhage (dual thrombosis and venous aneurysms). Current classifications appear insufficient to identify a wide range of conditions that ultimately determine the organization of the cortical venous drainage. Intermediate degrees of venous congestion correlate better with the clinical risk than the simple definition of cortical reflux. The angiographic aspects of venous drainage presented in this study may prove useful to assess dAVF hemodynamic characteristics and identify conditions at higher clinical risk. Copyright © 2017 by the Congress of Neurological Surgeons

High-intensity focused ultrasound (HIFU) in prostate cancer: a single centre experience in patients with low, intermediate or high-risk of progression.

PubMed

Callea, Andrea; Piccinni, Roberto; Zizzi, Vito; Sblendorio, Domenico; Berardi, Bartolomeo; Tempesta, Antonio; Gala, Francesco Giuseppe; Traficante, Antonio

2010-12-01

High-intensity focused ultrasound (HIFU) is a minimally invasive treatment based on thermal ablation of tissues which are warmed up to 85 degrees C in the focal area. Clinical studies have shown such treatment modality to be safe and effective in the management of localised prostate cancer as well as of local recurrences after radical prostatectomy or radiotherapy. From May 2002 to June 2010, 171 patients with no previous treatment for prostate cancer, aged 44 to 86 years (mean 74.7) underwent 197 HIFU treatments; 22 patients needed a second treatment as the first was incomplete (4 patients) or because of recurrence (18 patients). The prognosis subgroups were defined as low-risk in 29 patients (clinical stage T1-T2a, PSA < or = 10 ng/mL and Gleason score lower than 7), intermediate-risk in 47 patients (clinical stage T2b or PSA 10 - 20 ng/mL or Gleason score of 7), and high-risk in 95 patients (clinical stage > or = T2c or PSA > 20 ng/mL or Gleason score higher than 7). At a mean follow-up of 67.9 months, biochemical success rate (PSA constantly < 0.5 ng/ml) was obtained in 84.2% of low and intermediate risk patients and in 43.1% of high risk patients; post-treatment biopsies (6 months after treatment) revealed no residual tumour in 93.4% of low or intermediate risk patients and in 63.1% of high risk patients. Radical prostatectomy remains the "gold standard" for localised prostate cancer. However, HIFU seems to be a promising alternative and less invasive treatment modality with an encouraging success rate, at least in the short-term, in patients with low and medium risk of progression, not candidates for radical surgery; in cancers with clinical stage > or = T2c, or PSA > 20 ng/mL, or Gleason score higher than 7 seems to get good results in about half of patients.

Naloxone Distribution and Training for Patients with High-Risk Opioid Use in a Veterans Affairs Community-Based Primary Care Clinic.

PubMed

Raffel, Katie E; Beach, Leila Y; Lin, John; Berchuck, Jacob E; Abram, Shelly; Markle, Elizabeth; Patel, Shalini

2018-03-30

Naloxone distribution has historically been implemented in a community-based, expanded public health model; however, there is now a need to further explore primary care clinic-based naloxone delivery to effectively address the nationwide opioid epidemic. To create a general medicine infrastructure to identify patients with high-risk opioid use and provide 25% of this population with naloxone autoinjector prescription and training within a 6-month period. The quality improvement study was conducted at an outpatient clinic serving 1238 marginally housed veterans with high rates of comorbid substance use and mental health disorders. Patients at high risk of opioid-related adverse events were identified using the Stratification Tool for Opioid Risk Management and were contacted to participate in a one-on-one, 15-minute, hands-on naloxone training led by nursing staff. The number of patients identified at high risk and rates of naloxone training/distribution. There were 67 patients identified as having high-risk opioid use. None of these patients had been prescribed naloxone at baseline. At the end of the intervention, 61 patients (91%) had been trained in the use of naloxone. Naloxone was primarily distributed by licensed vocational nurses (42/61, 69%). This study demonstrates the feasibility of high-risk patient identification and of a primary care-based and nursing-championed naloxone distribution model. This delivery model has the potential to provide access to naloxone to a population of patients with opioid use who may not be engaged in mental health or specialty care.

Comparison of the clinical performances of the AdvanSure HPV Screening Real-Time PCR, the Abbott Real-Time High-Risk HPV Test, and the Hybrid Capture High-Risk HPV DNA Test for Cervical Cancer Screening.

PubMed

Chung, Hae-Sun; Hahm, Chorong; Lee, Miae

2014-09-01

The clinical performance of three human papillomavirus (HPV) DNA commercial assays for cervical cancer screening was evaluated; the AdvanSure HPV Screening Real-Time PCR (AdvanSure PCR; LG Life Sciences) that was developed recently for the detection of both high-risk and low-risk genotypes, the Abbott RealTime High-Risk HPV Test (Abbott PCR; Abbott Molecular) and the Hybrid Capture High-Risk HPV DNA test (HC2; Qiagen). The three different HPV DNA tests were compared using cytology samples obtained from 619 women who underwent routine cervical cancer screening. The gold-standard assay was histopathological confirmation of cervical intraepithelial neoplasia of grade 2 or worse. The clinical sensitivities of the AdvanSure PCR, the Abbott PCR and the HC2 for the detection of cervical intraepithelial neoplasia of grade 2 or worse were 95.5%, 95.5% and 100%, respectively, while the clinical specificities were 61.6%, 86.4% and 83.3%, respectively. There were no significant differences in the clinical sensitivities of the Abbott PCR and the AdvanSure PCR compared to the HC2. The clinical specificities of the Abbott PCR and the AdvanSure PCR for the detection of HPV types 16/18 were 97.8% and 98.5%, respectively. For cervical cancer screening, all three tests showed relatively good clinical sensitivities, but the AdvanSure PCR had lower clinical specificity than the Abbott PCR and the HC2. The AdvanSure PCR and the Abbott PCR assays have the advantage of being automated and the ability to distinguish between HPV types 16/18 and other HPV types. The two real-time PCR assays could be useful tools in HPV testing for cervical cancer screening. Copyright © 2014 Elsevier B.V. All rights reserved.

Clinical risk management in obstetrics.

PubMed

Holden, Deborah A; Quin, Maureen; Holden, Des P

2004-04-01

Over recent years there has been a growing appreciation that a small but significant proportion of patients experience (sometimes serious) adverse events in the hands of health care workers. Although research in this area is very much in its infancy there has been an increasing move towards applying principles of risk management from industry to health care organizations. With the particularly disastrous and costly nature of adverse outcomes in obstetrics it is appropriate to review clinical risk management issues in maternity. This review explores the appropriateness of applying lessons learned in industry to maternity. The classification of errors into individual and latent, or organizational, is examined. Furthermore, the way in which these errors can be identified and subsequently analysed, with examples from maternity units in the UK and USA, is discussed. The importance of an educational and supportive environment, rather than a blame culture, for both reporting of incidents and learning from adverse outcomes is emphasized. Improvement in patient experience of health care rests not just with improved treatments, but also with a reduction in the adverse events which occur in health care institutions. The principles by which risk can be identified prospectively and retrospectively, and the mechanisms for both local risk management and regional/national reporting and learning are considered.

Are prenatal care resources distributed efficiently across high-risk and low-risk mothers?

PubMed

Mukhopadhyay, Sankar; Wendel, Jeanne

2008-09-01

The Institute for Clinical Systems Improvement recommends reducing the number of prenatal care visits recommended for low-risk women, citing evidence from a randomized clinical trial indicating that the reduction would not adversely impact infant health. We investigate the implicit hypothesis that prenatal care resources are not distributed efficiently across high-risk and low-risk women. Using clinic-reported prenatal care and an inclusive measure of infant health, we report evidence indicating inefficient resource utilization: prenatal care only boosts infant health when mothers have specific pre-existing diagnoses, but women with high potential to benefit from care do not obtain more care than other women.

Patient-reported outcomes following stereotactic body radiation therapy for clinically localized prostate cancer

PubMed Central

2014-01-01

Background Stereotactic body radiation therapy (SBRT) delivers high doses of radiation to the prostate while minimizing radiation to adjacent normal tissues. Large fraction sizes may increase the risk of functional decrements. Treatment-related bother may be more important to a patient than treatment-related dysfunction. This study reports on patient-reported outcomes following SBRT for clinically localized prostate cancer. Methods Between August 2007 and July 2011, 228 consecutive hormone-naïve patients with clinically localized prostate cancer were treated with 35–36.25 Gy SBRT delivered using the CyberKnife Radiosurgical System (Accuray) in 5 fractions. Quality of life was assessed using the American Urological Association Symptom Score (AUA) and the Expanded Prostate Cancer Index Composite (EPIC)-26. Urinary symptom flare was defined as an AUA score 15 or more with an increase of 5 or more points above baseline 6 months after treatment. Results 228 patients (88 low-, 126 intermediate- and 14 high-risk) at a median age of 69 (44–90) years received SBRT with a minimum follow-up of 24 months. EPIC urinary and bowel summary scores declined transiently at 1 month and experienced a second, more protracted decline between 9 months and 18 months before returning to near baseline 2 years post-SBRT. 14.5% of patients experienced late urinary symptom flare following treatment. Patients who experienced urinary symptom flare had poorer bowel quality of life following SBRT. EPIC scores for urinary bother declined transiently, first at 1 month and again at 12 months, before approaching pre-treatment scores by 2 years. Bowel bother showed a similar pattern, but the second decline was smaller and lasted 9 months to 18 months. EPIC sexual summary and bother scores progressively declined over the 2 years following SBRT without recovery. Conclusions In the first 2 years, the impact of SBRT on urination and defecation was minimal. Transient late increases in

Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements.

PubMed

Zheng, Sarah Y; Dhruva, Sanket S; Redberg, Rita F

2017-08-15

High-risk medical devices often undergo modifications, which are approved by the US Food and Drug Administration (FDA) through various kinds of premarket approval (PMA) supplements. There have been multiple high-profile recalls of devices approved as PMA supplements. To characterize the quality of the clinical studies and data (strength of evidence) used to support FDA approval of panel-track supplements (a type of PMA supplement pathway that is used for significant changes in a device or indication for use and always requires clinical data). Descriptive study of clinical studies supporting panel-track supplements approved by the FDA between April 19, 2006, and October 9, 2015. Panel-track supplement approval. Methodological quality of studies including randomization, blinding, type of controls, clinical vs surrogate primary end points, use of post hoc analyses, and reporting of age and sex. Eighty-three clinical studies supported the approval of 78 panel-track supplements, with 71 panel-track supplements (91%) supported by a single study. Of the 83 studies, 37 (45%) were randomized clinical trials and 25 (30%) were blinded. The median number of patients per study was 185 (interquartile range, 75-305), and the median follow-up duration was 180 days (interquartile range, 84-270 days). There were a total of 150 primary end points (mean [SD], 1.8 [1.2] per study), and 57 primary end points (38%) were compared with controls. Of primary end points with controls, 6 (11%) were retrospective controls and 51 (89%) were active controls. One hundred twenty-one primary end points (81%) were surrogate end points. Thirty-three studies (40%) did not report age and 25 (30%) did not report sex for all enrolled patients. The FDA required postapproval studies for 29 of 78 (37%) panel-track supplements. Among clinical studies used to support FDA approval of high-risk medical device modifications, fewer than half were randomized, blinded, or controlled, and most primary outcomes were

Clinically important improvement in function is common in people with or at high risk of knee OA: the MOST study

PubMed Central

White, Daniel K.; Keysor, Julie J.; LaValley, Michael P.; Lewis, Cora E.; Torner, James C.; Nevitt, Michael C.; Felson, David T.

2010-01-01

To calculate the frequency of clinically important improvement in function over 30 months and identify risk factors in people who have or are at risk of knee OA. Subjects were from MOST, a longitudinal study of persons with or at high risk of knee OA. We defined Minimal Clinically Important Improvement (MCII) with WOMAC physical function using three different methods. Baseline risk factors tested for improvement included age, gender, educational attainment, presence of radiographic knee OA (ROA), the number of comorbidities, Body Mass Index (BMI), knee pain, walking speed, isokinetic knee extensor strength, depressive symptoms, physical activity, and medication usage. We used logistic regression to evaluate the association of baseline risk factors with MCII. Of the 1801 subjects (age= 63, BMI= 31, 63% female), most had mild limitations in baseline function (WOMAC = 19 +/− 11). Regardless how defined, a substantial percentage of subjects (24%–39%) reached MCII at 30 months. Compared to their counterparts, people with MCII were less likely to have ROA and to use medications, and were more likely to have a lower BMI, less knee pain, a faster walking speed, more knee strength, and fewer depressive symptoms. After adjustment, MCII was 40% to 50% less likely in those with ROA, and 1.9 to 2.0 times more likely in those walking 1.0 m/s faster than counterparts. Clinically important improvement is frequent in people with or at high risk of knee OA. The absence of ROA and a faster walking speed appear to be associated with clinically important improvements. PMID:20395640

Specialist antenatal clinics for women at high risk of preterm birth: a systematic review of qualitative and quantitative research.

PubMed

Malouf, Reem; Redshaw, Maggie

2017-02-02

Preterm birth (PTB) is the leading cause of perinatal morbidity and mortality. Women with previous prenatal loss are at higher risk of preterm birth. A specialist antenatal clinic is considered as one approach to improve maternity and pregnancy outcomes. A systematic review of quantitative, qualitative and mixed method studies conducted on women at high risk of preterm birth (PTB). The review primary outcomes were to report on the specialist antenatal clinics effect in preventing or reducing preterm birth, perinatal mortality and morbidity and women's perceptions and experiences of a specialist clinic whether compared or not compared with standard antenatal care. Other secondary maternal, infant and economic outcomes were also determined. A comprehensive search strategy was carried out in English within electronic databases as far back as 1980. The reviewers selected studies, assessed the quality, and extracted data independently. Results were summarized and tabulated. Eleven studies fully met the review inclusion criteria, ten were quantitative design studies and only one was a qualitative design study. No mixed method design study was included in the review. All were published after 1989, seven were conducted in the USA and four in the UK. Results from five good to low quality randomised controlled trials (RCTs), all conducted before 1990, did not illustrate the efficacy of the clinic in reducing preterm birth. Whereas results from more recent low quality cohort studies showed some positive neonatal outcomes. Themes from one good quality qualitative study reflected on the emotional and psychological need to reduce anxiety and stress of women referred to such a clinic. Women expressed their negative emotional responses at being labelled as high risk and positive responses to being assessed and treated in the clinic. Women also reported that their partners were struggling to cope emotionally. Findings from this review were mixed. Evidence from cohort studies

Increasing the clinical efficacy of NK and antibody-mediated cancer immunotherapy: potential predictors of successful clinical outcome based on observations in high-risk neuroblastoma.

PubMed

Koehn, Tony A; Trimble, Lori L; Alderson, Kory L; Erbe, Amy K; McDowell, Kimberly A; Grzywacz, Bartosz; Hank, Jacquelyn A; Sondel, Paul M

2012-01-01

Disease recurrence is frequent in high-risk neuroblastoma (NBL) patients even after multi-modality aggressive treatment [a combination of chemotherapy, surgical resection, local radiation therapy, autologous stem cell transplantation, and cis-retinoic acid (CRA)]. Recent clinical studies have explored the use of monoclonal antibodies (mAbs) that bind to disialoganglioside (GD(2)), highly expressed in NBL, as a means to enable immune effector cells to destroy NBL cells via antibody-dependent cell-mediated cytotoxicity (ADCC). Preclinical data indicate that ADCC can be more effective when appropriate effector cells are activated by cytokines. Clinical studies have pursued this by administering anti-GD(2) mAb in combination with ADCC-enhancing cytokines (IL2 and GM-CSF), a regimen that has demonstrated improved cancer-free survival. More recently, early clinical studies have used a fusion protein that consists of the anti-GD(2) mAb directly linked to IL2, and anti-tumor responses were seen in the Phase II setting. Analyses of genes that code for receptors that influence ADCC activity and natural killer (NK) cell function [Fc receptor (FcR), killer immunoglublin-like receptor (KIR), and KIR-ligand (KIR-L)] suggest patients with anti-tumor activity are more likely to have certain genotype profiles. Further analyses will need to be conducted to determine whether these genotypes can be used as predictive markers for favorable therapeutic outcome. In this review, we discuss factors that affect response to mAb-based tumor therapies such as hu14.18-IL2. Many of our observations have been made in the context of NBL; however, we will also include some observations made with mAbs targeting other tumor types that are consistent with results in NBL. Therefore, we hypothesize that the NBL observations discussed here may also be relevant to mAb therapy for other cancers, in which ADCC is known to play a role.

Risk perception of tsunami in the community of Arauco, Chile - a contribution of risk perception to disaster risk management at local level

NASA Astrophysics Data System (ADS)

Kubisch, M. Sc. Susanne; Edilia Jaque Castillo, Dra.; Braun, JProf. Andreas Ch., ,, Dr.

2017-04-01

The research was carried out in the city center of the coastal community of Arauco, Central Chile. The community of Arauco was one of the most affected communities of the tsunami in Chile, the 27th of February 2010. For the data evaluation, the affected inhabitants of the community have been surveyed via standardized questionnaires. Furthermore experts of different fields, amongst others, Disaster Risk Management (DRM), risk education, urban and regional planning, as well as geology have been consulted in form of expert interviews. The results revealed a high risk perception part of the affected community and a weakness of DRM especially at local level, which opens a gap between the evaluation and treatment of risk by experts and risk perception of the affected community. The risk perception of the affected community, here, is predominantly determined by ecological vulnerability, expressed in direct and indirect experience of a tsunami and by institutional vulnerability, expressed among others by a weakness of DRM at local level and a mistrust in responsible institutions for DRM. Due to the institutional vulnerability and the mistrust in responsible institutions we recommend a Community Based Approach (CBA) to strengthen DRM at local level and to take advantage of the high risk perception and knowledge of the affected community. Involving the community in DRM, we assume to close the gap between risk evaluation of experts and risk perception of the inhabitants and to come up with the unique necessities and conditions at local level. Especially in centralized countries, DRM is less effective, because at the one hand, decisions are made distant from the affected communities, so that measures often do not come up with the unique conditions and necessities at local level, and on the other hand measures often do not find acceptance by the affected community. Furthermore centralized DRM is often not effective and quick in response in case of emergency. Another obstacle

Primary Cryotherapy for High-Grade Clinically Localized Prostate Cancer: Oncologic and Functional Outcomes from the COLD Registry.

PubMed

Tay, Kae Jack; Polascik, Thomas J; Elshafei, Ahmed; Cher, Michael L; Given, Robert W; Mouraviev, Vladimir; Ross, Ashley E; Jones, J Stephen

2016-01-01

To evaluate the oncological and functional outcomes of primary cryotherapy in men with clinically localized, high-grade prostate cancer. We included all men with biopsy Gleason score ≥8, localized (cT1-2) disease with a serum prostate-specific antigen (PSA) ≤50 ng/mL from the Cryo On-Line Data (COLD) registry. The primary outcome was biochemical progression free survival (BPFS) as defined by the Phoenix criteria (nadir PSA +2 ng/mL). Secondary outcomes of continence (defined as strictly no leak) and potency (able to have intercourse) were patient reported. Factors influencing BPFS were evaluated individually using Kaplan Meier and in a multivariate model using Cox regression. Altogether, 300 men were included for analysis. The median follow-up was 18.2 months (mean 28.4) and median BPFS was 69.8 months. Based on Kaplan-Meier analysis, the estimated 2- and 5-year BPFS rate was 77.2% and 59.1%, respectively. Neoadjuvant hormonal therapy was administered to 41% of men and this tended to occur in men with larger prostates, likely as a technical consideration for downsizing before cryosurgery. At multivariate analysis, the presence of Gleason score 9 or 10 (Hazard Ratio [HR] 1.9) and a posttreatment PSA nadir of ≥0.4 ng/mL (HR 5.7) were the only significant variables associated with biochemical progression using Cox regression. Complete continence was noted in 90.5% of men and potency in 17% of men at the 12-month follow-up. The incidence of rectourethral fistulae and urinary retention requiring intervention beyond temporary catheterization was 1.3% and 3.3%, respectively. Primary cryotherapy appears to be effective and safe in the community setting for high-grade, clinically localized prostate cancer in the short term.

Naloxone Distribution and Training for Patients with High-Risk Opioid Use in a Veterans Affairs Community-Based Primary Care Clinic

PubMed Central

Raffel, Katie E; Beach, Leila Y; Lin, John; Berchuck, Jacob E; Abram, Shelly; Markle, Elizabeth; Patel, Shalini

2018-01-01

Context Naloxone distribution has historically been implemented in a community-based, expanded public health model; however, there is now a need to further explore primary care clinic-based naloxone delivery to effectively address the nationwide opioid epidemic. Objective To create a general medicine infrastructure to identify patients with high-risk opioid use and provide 25% of this population with naloxone autoinjector prescription and training within a 6-month period. Design The quality improvement study was conducted at an outpatient clinic serving 1238 marginally housed veterans with high rates of comorbid substance use and mental health disorders. Patients at high risk of opioid-related adverse events were identified using the Stratification Tool for Opioid Risk Management and were contacted to participate in a one-on-one, 15-minute, hands-on naloxone training led by nursing staff. Main Outcome Measures The number of patients identified at high risk and rates of naloxone training/distribution. Results There were 67 patients identified as having high-risk opioid use. None of these patients had been prescribed naloxone at baseline. At the end of the intervention, 61 patients (91%) had been trained in the use of naloxone. Naloxone was primarily distributed by licensed vocational nurses (42/61, 69%). Conclusion This study demonstrates the feasibility of high-risk patient identification and of a primary care-based and nursing-championed naloxone distribution model. This delivery model has the potential to provide access to naloxone to a population of patients with opioid use who may not be engaged in mental health or specialty care. PMID:29616917

The no-show rate in a high-risk obstetric clinic.

PubMed

Campbell, J D; Chez, R A; Queen, T; Barcelo, A; Patron, E

2000-10-01

We wished to determine the reasons for an average missed appointment rate of 28% in a high-risk pregnancy clinic. Only 41% of the 261 women in the study group could be reached by telephone. The reasons included not having a phone, the phone had been disconnected, incorrect phone number on the chart, the patient had moved, and the patient did not respond to the answering machine message. The reasons for missing the appointment included lack of transportation, scheduling problems, overslept or forgot, presence of a sick child or relative, and lack of child care. The response of patients to assessing prenatal care may reflect their priority of medical care relative to other priorities associated with day-to-day existence. There may be a baseline missed appointment rate for prenatal care in lower socioeconomic populations of women. The commitment of personnel time and energy to attempt to modify the no-show rate should be reexamined.

Venous Thromboembolism Risk and Adequacy of Prophylaxis in High Risk Pregnancy in the Arabian Gulf

PubMed Central

Alsayegh, Faisal; Al-Jassar, Waleed; Wani, Salima; Tahlak, Muna; Al-Bahar, Awatef; Al-Kharusi, Lamya; Al-Tamimi, Halima; El-Taher, Faten; Mahmood, Naeema; Al-Zakwani, Ibrahim

2016-01-01

Objectives: To estimate the prevalence of venous thromboembolism (VTE) risk factors in pregnancy and the proportion of pregnancies at risk of VTE that received the recommended prophylaxis according to the American College of Chest Physicians (ACCP) 2012 published guidelines in antenatal clinics in the Arabian Gulf. Methods: The evaluation of venous thromboembolism (EVE)-Risk project was a non-interventional, cross-sectional, multi-centre, multi-national study of all eligible pregnant women (≥17 years) screened during antenatal clinics from 7 centres in the Arabian Gulf countries (United Arab Emirates, Kuwait, Bahrain, Qatar and Oman). Pregnant women were recruited during a 3-month period between September and December 2012. Results: Of 4,131 screened pregnant women, 32% (n=1,337) had ≥1 risk factors for VTE. Common VTE risk factors included obesity (76%), multiparity (33%), recurrent miscarriages (9.1%), varicose veins (6.9%), thrombophilia (2.6%), immobilization (2.0%), sickle cell disease (2.8%) and previous VTE (1.6%). Only 8.3% (n=111) of the high risk patients were on the recommended VTE prophylaxis. Enoxaparin was used in 80% (n=89) of the cases followed by tinzaparin (4%; n=4). Antiplatelet agents were prescribed in 11% (n=149) of pregnant women. Of those on anticoagulants (n=111), 59% (n=66) were also co-prescribed antiplatelet agents. Side effects (mainly local bruising at the injection site) were reported in 12% (n=13) of the cases. Conclusion: A large proportion of pregnant women in the Arabian Gulf countries have ≥1 VTE risk factor with even a smaller fraction on prophylaxis. VTE risk assessment must be adopted to identify those at risk who would need VTE prophylaxis. PMID:26517701

[The relevance of clinical risk management].

PubMed

Gulino, Matteo; Vergallo, Gianluca Montanari; Frati, Paola

2011-01-01

Medical activity includes a risk of possible injury or complications for the patients, that should drive the Health Care Institutions to introduce and/ or improve clinical Risk management instruments. Although Italy is still lacking a National project of Clinical Risk Management, a number of efforts have been made by different Italian Regions to introduce instruments of risk management. In addition, most of National Health Care Institutions include actually a Department specifically in charge to manage the clinical risk. Despite the practical difficulties, the results obtained until now suggest that the risk management may represent a useful instrument to contribute to the reduction of errors in clinical conduct. Indeed, the introduction of adequate instruments of prevention and management of clinical risk may help to ameliorate the quality of health care Institution services.

Glucose-6-Phosphate Dehydrogenase Deficiency in Brazilian Children With Sickle Cell Anemia is not Associated With Clinical Ischemic Stroke or High-Risk Transcranial Doppler.

PubMed

Belisário, André Rolim; Rodrigues Sales, Rahyssa; Evelin Toledo, Nayara; Velloso-Rodrigues, Cibele; Maria Silva, Célia; Borato Viana, Marcos

2016-06-01

Stroke is a severe complication of sickle cell anemia (SCA). The role of glucose-6-phosphate dehydrogenase (G6PD) deficiency in the development of stroke in children with SCA is controversial. The aim of this study was to investigate the association of clinical ischemic stroke, high-risk transcranial Doppler measurements (TCD), and hematological features with molecular variants usually linked to G6PD deficiency or with the biochemical activity of G6PD in a cohort of 395 Brazilian children with SCA. G6PD activity was quantitatively determined using an enzymatic-colorimetric assay. G6PD mutations were determined by PCR-RFLP and sequencing. Clinical and hematological data were retrieved from the children's records. The prevalence of molecularly defined deficiency (hereafter, molecular deficiency) was 4.3% (95% confidence interval: 2.3-6.3%). The mean G6PD activity was 16.88 U/g hemoglobin (Hb) (standard error of the mean [SEM] 0.28) in the group without G6PD molecular deficiency and 8.43 (SEM 1.01) U/g Hb in the group with G6PD A(-) molecular deficiency. G6PD molecular deficiency was not associated with any hematological features. No effects of G6PD molecular deficiency on clinical ischemic stroke or high-risk TCD were detected. The mean G6PD activity was similar in children who had clinical ischemic stroke and in those without stroke. Similar results were obtained in analyses comparing children who had high-risk TCD and those without high-risk TCD. Our study demonstrated that G6PD molecular deficiency was not associated either with clinical ischemic stroke or high-risk TCD. Similarly, we found no associations between G6PD enzyme activity and stroke or high-risk TCD. Small sample size precludes definitive conclusions. © 2016 Wiley Periodicals, Inc.

Local Risk-Minimization for Defaultable Claims with Recovery Process

DOE Office of Scientific and Technical Information (OSTI.GOV)

Biagini, Francesca, E-mail: biagini@mathematik.uni-muenchen.de; Cretarola, Alessandra, E-mail: alessandra.cretarola@dmi.unipg.it

We study the local risk-minimization approach for defaultable claims with random recovery at default time, seen as payment streams on the random interval [0,{tau} Logical-And T], where T denotes the fixed time-horizon. We find the pseudo-locally risk-minimizing strategy in the case when the agent information takes into account the possibility of a default event (local risk-minimization with G-strategies) and we provide an application in the case of a corporate bond. We also discuss the problem of finding a pseudo-locally risk-minimizing strategy if we suppose the agent obtains her information only by observing the non-defaultable assets.

Clinical Evidence Supporting US Food and Drug Administration Premarket Approval of High-Risk Otolaryngologic Devices, 2000-2014.

PubMed

Rathi, Vinay K; Wang, Bo; Ross, Joseph S; Downing, Nicholas S; Kesselheim, Aaron S; Gray, Stacey T

2017-02-01

The US Food and Drug Administration (FDA) approves high-risk medical devices based on premarket pivotal clinical studies demonstrating reasonable assurance of safety and effectiveness and may require postapproval studies (PAS) to further inform benefit-risk assessment. We conducted a cross-sectional analysis using publicly available FDA documents to characterize industry-sponsored pivotal studies and PAS of high-risk devices used in the treatment of otolaryngologic diseases. Between 2000 and 2014, the FDA approved 23 high-risk otolaryngologic devices based on 28 pivotal studies. Median enrollment was 118 patients (interquartile range, 67-181), and median duration of longest primary effectiveness end point follow-up was 26 weeks (interquartile range, 16-96). Fewer than half were randomized (n = 13, 46%), blinded (n = 12, 43%), or controlled (n = 10, 36%). The FDA required 23 PASs for 16 devices (70%): almost two-thirds (n = 15, 65%) monitored long-term performance, and roughly one-third (n = 8, 35%) focused on subgroups. Otolaryngologists should be aware of limitations in the strength of premarket evidence when considering the use of newly approved devices.

Stroke Risk Perception in Atrial Fibrillation Patients is not Associated with Clinical Stroke Risk.

PubMed

Fournaise, Anders; Skov, Jane; Bladbjerg, Else-Marie; Leppin, Anja

2015-11-01

Clinical risk stratification models, such as the CHA2DS2-VASc, are used to assess stroke risk in atrial fibrillation (AF) patients. No study has yet investigated whether and to which extent these patients have a realistic perception of their personal stroke risk. The purpose of this study was to investigate and describe the association between AF patients' stroke risk perception and clinical stroke risk. In an observational cross-sectional study design, we surveyed 178 AF patients with a mean age of 70.6 years (SD 8.3) in stable anticoagulant treatment (65% treatment duration >12 months). Clinical stroke risk was scored through the CHA2DS2-VASc, and patients rated their perceived personal stroke risk on a 7-point Likert scale. There was no significant association between clinical stroke risk assessment and patients' stroke risk perception (rho = .025; P = .741). Approximately 60% of the high-risk patients had an unrealistic perception of their own stroke risk, and there was no significant increase in risk perception from those with a lower compared with a higher risk factor load (χ(2) = .010; P = .522). Considering possible negative implications in terms of lack of motivation for lifestyle behavior change and adequate adherence to the treatment and monitoring of vitamin K antagonist, the apparent underestimation of risk by large subgroups warrants attention and needs further investigation with regard to possible behavioral consequences. Copyright © 2015 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Genetic Alterations and Their Clinical Implications in High-Recurrence Risk Papillary Thyroid Cancer.

PubMed

Lee, Min-Young; Ku, Bo Mi; Kim, Hae Su; Lee, Ji Yun; Lim, Sung Hee; Sun, Jong-Mu; Lee, Se-Hoon; Park, Keunchil; Oh, Young Lyun; Hong, Mineui; Jeong, Han-Sin; Son, Young-Ik; Baek, Chung-Hwan; Ahn, Myung-Ju

2017-10-01

Papillary thyroid carcinomas (PTCs) frequently involve genetic alterations. The objective of this study was to investigate genetic alterations and further explore the relationships between these genetic alterations and clinicopathological characteristics in a high-recurrence risk (node positive, N1) PTC group. Tumor tissue blocks were obtained from 240 surgically resected patients with histologically confirmed stage III/IV (pT3/4 or N1) PTCs. We screened gene fusions using NanoString's nCounter technology and mutational analysis was performed by direct DNA sequencing. Data describing the clinicopathological characteristics and clinical courses were retrospectively collected. Of the 240 PTC patients, 207 (86.3%) had at least one genetic alteration, including BRAF mutation in 190 patients (79.2%), PIK3CA mutation in 25 patients (10.4%), NTRK1/3 fusion in six patients (2.5%), and RET fusion in 24 patients (10.0%). Concomitant presence of more than two genetic alterations was seen in 36 patients (15%). PTCs harboring BRAF mutation were associated with RET wild-type expression (p=0.001). RET fusion genes have been found to occur with significantly higher frequency in N1b stage patients (p=0.003) or groups of patients aged 45 years or older (p=0.031); however, no significant correlation was found between other genetic alterations. There was no trend toward favorable recurrence-free survival or overall survival among patients lacking genetic alterations. In the selected high-recurrence risk PTC group, most patients had more than one genetic alteration. However, these known alterations could not entirely account for clinicopathological features of high-recurrence risk PTC.

Irradiation with protons for the individualized treatment of patients with locally advanced rectal cancer: a planning study with clinical implications.

PubMed

Wolff, Hendrik Andreas; Wagner, Daniela Melanie; Conradi, Lena-Christin; Hennies, Steffen; Ghadimi, Michael; Hess, Clemens Friedrich; Christiansen, Hans

2012-01-01

Ongoing clinical trials aim to improve local control and overall survival rates by intensification of therapy regimen for patients with locally advanced rectal cancer. It is well known that whenever treatment is intensified, risk of therapy-related toxicity rises. An irradiation with protons could possibly present an approach to solve this dilemma by lowering the exposure to the organs-at-risk (OAR) without compromising tumor response. Twenty five consecutive patients were treated from 04/2009 to 5/2010. For all patients, four different treatment plans including protons, RapidArc, IMRT and 3D-conformal-technique were retrospectively calculated and analyzed according to dosimetric aspects. Detailed DVH-analyses revealed that protons clearly reduced the dose to the OAR and entire normal tissue when compared to other techniques. Furthermore, the conformity index was significantly better and target volumes were covered consistent with the ICRU guidelines. Planning results suggest that treatment with protons can improve the therapeutic tolerance for the irradiation of rectal cancer, particularly for patients scheduled for an irradiation with an intensified chemotherapy regimen and identified to be at high risk for acute therapy-related toxicity. However, clinical experiences and long-term observation are needed to assess tumor response and related toxicity rates. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Clinical and histopathological factors affecting failed sentinel node localization in axillary staging for breast cancer.

PubMed

Dordea, Matei; Colvin, Hugh; Cox, Phil; Pujol Nicolas, Andrea; Kanakala, Venkat; Iwuchukwu, Obi

2013-04-01

Sentinel lymph node biopsy (SLNB) has become the standard of care in axillary staging of clinically node-negative breast cancer patients. To analyze reasons for failure of SLN localization by means of a multivariate analysis of clinical and histopathological factors. We performed a review of 164 consecutive breast cancer patients who underwent SLNB. A superficial injection technique was used. 9/164 patients failed to show nodes. In 7/9 patients no evidence of radioactivity or blue dye was observed. Age and nodal status were the only statistically significant factors (p < 0.05). For every unit increase in age there was a 9% reduced chance of failed SLN localization. Patients with negative nodal status have 90% reduced risk of failed sentinel node localization than patients with macro or extra capsular nodal invasion. The results suggest that altered lymphatic dynamics secondary to tumour burden may play a role in failed sentinel node localization. We showed that in all failed localizations the radiocolloid persisted around the injection site, showing limited local diffusion only. While clinical and histopathological data may provide some clues as to why sentinel node localization fails, we further hypothesize that integrity of peri-areolar lymphatics is important for successful localization. Copyright © 2012 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.

Prostate cancer risk prediction in a urology clinic in Mexico

PubMed Central

Liang, Yuanyuan; Messer, Jamie C; Louden, Christopher; Jimenez-Rios, Miguel A; Thompson, Ian M; Camarena-Reynoso, Hector R

2012-01-01

Objectives To evaluate factors affecting the risk of prostate cancer (PCa) and high-grade disease (HGPCa, Gleason score ≥7) in a Mexican referral population, with comparison to the Prostate Cancer Prevention Trial Prostate Cancer Risk Calculator (PCPTRC). Methods and Materials From a retrospective study of 826 patients who underwent prostate biopsy between January 2005 and December 2009 at the Instituto Nacional de Cancerología, Mexico, logistic regression was used to assess the effects of age, prostate-specific antigen (PSA), digital rectal exam (DRE), first-degree family history of PCa, and history of a prior prostate biopsy on PCa and HGPCa separately. Internal discrimination, goodness-of-fit and clinical utility of the resulting models were assessed with comparison to the PCPTRC. Results Rates of both PCa (73.2%) and HGPCa (33.3%) were high among referral patients in this Mexican urology clinic. The PCPTRC generally underestimated the risk of PCa but overestimated the risk of HGPCa. Four factors influencing PCa on biopsy were logPSA, DRE, family history and a prior biopsy history (all p<0.001). The internal AUC of the logistic model was 0.823 compared to 0.785 of the PCPTRC for PCa (p<0.001). The same four factors were significantly associated with HGPCa as well and the AUC was 0.779 compared to 0.766 of the PCPTRC for HGPCa (p=0.13). Conclusions Lack of screening programs or regular urological checkups in Mexico imply that men typically first reach specialized clinics with a high cancer risk. This renders diagnostic tools developed on comparatively healthy populations, such as the PCPTRC, of lesser utility. Continued efforts are needed to develop and externally validate new clinical diagnostic tools specific to high-risk referral populations incorporating new biomarkers and more clinical characteristics. PMID:22306115

Prostate cancer risk prediction in a urology clinic in Mexico.

PubMed

Liang, Yuanyuan; Messer, Jamie C; Louden, Christopher; Jimenez-Rios, Miguel A; Thompson, Ian M; Camarena-Reynoso, Hector R

2013-10-01

To evaluate factors affecting the risk of prostate cancer (CaP) and high-grade disease (HGCaP, Gleason score ≥ 7) in a Mexican referral population, with comparison to the Prostate Cancer Prevention Trial Prostate Cancer Risk Calculator (PCPTRC). From a retrospective study of 826 patients who underwent prostate biopsy between January 2005 and December 2009 at the Instituto Nacional de Cancerología, Mexico, logistic regression was used to assess the effects of age, prostate-specific antigen (PSA), digital rectal exam (DRE), first-degree family history of CaP, and history of a prior prostate biopsy on CaP and HGCaP, separately. Internal discrimination, goodness-of-fit, and clinical utility of the resulting models were assessed with comparison to the PCPTRC. Rates of both CaP (73.2%) and HGCaP (33.3%) were high among referral patients in this Mexican urology clinic. The PCPTRC generally underestimated the risk of CaP but overestimated the risk of HGCaP. Four factors influencing CaP on biopsy were logPSA, DRE, family history and a prior biopsy history (all P < 0.001). The internal AUC of the logistic model was 0.823 compared with 0.785 of the PCPTRC for CaP (P < 0.001). The same 4 factors were significantly associated with HGCaP as well and the AUC was 0.779 compared with 0.766 of the PCPTRC for HGCaP (P = 0.13). Lack of screening programs or regular urologic checkups in Mexico imply that men typically first reach specialized clinics with a high cancer risk. This renders diagnostic tools developed on comparatively healthy populations, such as the PCPTRC, of lesser utility. Continued efforts are needed to develop and externally validate new clinical diagnostic tools specific to high-risk referral populations incorporating new biomarkers and more clinical characteristics. Copyright © 2013 Elsevier Inc. All rights reserved.

Stigma related to labels and symptoms in individuals at clinical high-risk for psychosis.

PubMed

Yang, Lawrence H; Link, Bruce G; Ben-David, Shelly; Gill, Kelly E; Girgis, Ragy R; Brucato, Gary; Wonpat-Borja, Ahtoy J; Corcoran, Cheryl M

2015-10-01

Despite advances that the psychosis "clinical high-risk" (CHR) identification offers, risk of stigma exists. Awareness of and agreement with stereotypes has not yet been evaluated in CHR individuals. Furthermore, the relative stigma associated with symptoms, as opposed to the label of risk, is not known, which is critical because CHR identification may reduce symptom-related stigma. Thirty-eight CHR subjects were ascertained using standard measures from the Center of Prevention and Evaluation/New York State Psychiatric Institute/ Columbia University. Labeling-related measures adapted to the CHR group included "stereotype awareness and self-stigma" ("Stereotype awareness", "Stereotype Agreement", "Negative emotions [shame]"), and a parallel measure of "Negative emotions (shame)" for symptoms. These measures were examined in relation to symptoms of anxiety and depression, adjusting for core CHR symptoms (e.g. attenuated psychotic symptoms). CHR participants endorsed awareness of mental illness stereotypes, but largely did not themselves agree with these stereotypes. Furthermore, CHR participants described more stigma associated with symptoms than they did with the risk-label itself. Shame related to symptoms was associated with depression, while shame related to the risk-label was associated with anxiety. Both stigma of the risk-label and of symptoms contribute to the experience of CHR individuals. Stereotype awareness was relatively high and labeling-related shame was associated with increased anxiety. Yet limited agreement with stereotypes indicated that labeling-related stigma had not fully permeated self-conceptions. Furthermore, symptom-related stigma appeared more salient overall and was linked with increased depression, suggesting that alleviating symptom-related shame via treating symptoms might provide major benefit. Copyright © 2015. Published by Elsevier B.V.

Consistent high clinical pregnancy rates and low ovarian hyperstimulation syndrome rates in high-risk patients after GnRH agonist triggering and modified luteal support: a retrospective multicentre study.

PubMed

Iliodromiti, Stamatina; Blockeel, Christophe; Tremellen, Kelton P; Fleming, Richard; Tournaye, Herman; Humaidan, Peter; Nelson, Scott M

2013-09-01

Are clinical pregnancy rates satisfactory and the incidence of OHSS low after GnRH agonist trigger and modified intensive luteal support in patients with a high risk of ovarian hyperstimulation syndrome (OHSS)? GnRH agonist trigger combined with 1500 IU hCG at the time of oocyte retrieval and subsequent estradiol and progesterone replacement in OHSS high-risk patients can facilitate fresh embryo transfer with high clinical pregnancy rates and a low risk of severe OHSS. Conventional luteal support packages are inadequate to facilitate a fresh transfer after a GnRH agonist trigger. A low dose of hCG (1500 IU) after oocyte aspiration can be used to replace the actions of early luteal LH to sustain implantation and the function of the early corpus luteum, although the level of risk of severe OHSS with this strategy is unclear. This international multicentre retrospective case study, including 275 women at high risk of OHSS, was undertaken during the period January 2011-December 2012. Women were identified as at high risk of OHSS, based on IVF response, ovarian reserve characteristics and previous history of having had treatment, in three clinical IVF centres in UK, Belgium and Australia. All three centres used a GnRH agonist trigger followed by one bolus of 1500 IU hCG 1h after oocyte retrieval. Moreover, the luteal phase was supported with daily vaginal progesterone and twice daily estradiol valerate. A total of 275 autologous cycles with fresh transfer were undertaken in a cohort of high-risk women as defined by baseline characteristics [median (interquartile range)]: age 31.6 (29-35) years, antral follicle count median 25 (18-34) and anti-Müllerian hormone median 49.1 pmol/l (35.2-69.3). At the end of stimulation, the peak estradiol median of 12 000 pmol/l (9400-15 914) and the mean oocyte yield of 17.8 ± 8.4 confirmed a high response. The overall clinical pregnancy rate was 41.8% per cycle started, with only two cases of severe OHSS reported (0.72%). No

Early identification and high-risk strategies for bipolar disorder.

PubMed

Correll, Christoph U; Penzner, Julie B; Lencz, Todd; Auther, Andrea; Smith, Christopher W; Malhotra, Anil K; Kane, John M; Cornblatt, Barbara A

2007-06-01

To describe and compare the relative merits of different identification strategies for individuals at risk for bipolar disorder (BPD). Selective review of data that support early identification in BPD, with a particular focus on emerging clinical high-risk strategies. Early detection of individuals at risk for BPD can utilize genetic, endophenotypic and clinical methods. Most published work focuses on genetic familial endophenotypic risk markers for BPD. However, despite encouraging results, problems with specificity and sensitivity limit the application of these data to early prevention programs. In addition, offspring studies of BPD patients systematically exclude the majority of subjects without a first-degree bipolar relative. On the other hand, emerging work in the clinical-high-risk arena has already produced encouraging results. Although still preliminary, the identification of individuals in subsyndromal or attenuated symptom 'prodromal' stages of BPD seems to be an under-researched area that holds considerable promise deserving increased attention. Required next steps include the development of rating tools for attenuated and subsyndromal manic and depressive symptoms and of prodromal criteria that will allow prodromal symptomatology to be systematically studied in patients with recent-onset bipolar, as well as in prospective population-based phenomenology trials and attenuated symptom-based high-risk studies. Given the current limitations of each early identification method, combining clinical, endophenotypic and genetic strategies will increase prediction accuracy. Since reliable biological markers for BPD have not been established and since most patients with BPD lack a first-degree relative with this disorder, clinical high-risk approaches have great potential to inform early identification and intervention programs.

A multigene expression assay to predict local recurrence risk for ductal carcinoma in situ of the breast.

PubMed

Solin, Lawrence J; Gray, Robert; Baehner, Frederick L; Butler, Steven M; Hughes, Lorie L; Yoshizawa, Carl; Cherbavaz, Diana B; Shak, Steven; Page, David L; Sledge, George W; Davidson, Nancy E; Ingle, James N; Perez, Edith A; Wood, William C; Sparano, Joseph A; Badve, Sunil

2013-05-15

For women with ductal carcinoma in situ (DCIS) of the breast, the risk of developing an ipsilateral breast event (IBE; defined as local recurrence of DCIS or invasive carcinoma) after surgical excision without radiation is not well defined by clinical and pathologic characteristics. The Oncotype DX breast cancer assay was performed for patients with DCIS treated with surgical excision without radiation in the Eastern Cooperative Oncology Group (ECOG) E5194 study. The association of the prospectively defined DCIS Score (calculated from seven cancer-related genes and five reference genes) with the risk of developing an IBE was analyzed using Cox regression. All statistical tests were two-sided. There were 327 patients with adequate tissue for analysis. The continuous DCIS Score was statistically significantly associated with the risk of developing an IBE (hazard ratio [HR] = 2.31, 95% confidence interval [CI] = 1.15 to 4.49; P = .02) when adjusted for tamoxifen use (prespecified primary analysis) and with invasive IBE (unadjusted HR = 3.68, 95% CI = 1.34 to 9.62; P = .01). For the prespecified DCIS risk groups of low, intermediate, and high, the 10-year risks of developing an IBE were 10.6%, 26.7%, and 25.9%, respectively, and for an invasive IBE, 3.7%, 12.3%, and 19.2%, respectively (both log rank P ≤ .006). In multivariable analyses, factors associated with IBE risk were DCIS Score, tumor size, and menopausal status (all P ≤ .02). The DCIS Score quantifies IBE risk and invasive IBE risk, complements traditional clinical and pathologic factors, and provides a new clinical tool to improve selecting individualized treatment for women with DCIS who meet the ECOG E5194 criteria.

Management of high-risk perioperative systems.

PubMed

Dain, Steven

2006-06-01

The perioperative system is a complex system that requires people, materials, and processes to come together in a highly ordered and timely manner. However, when working in this high-risk system, even well-organized, knowledgeable, vigilant, and well-intentioned individuals will eventually make errors. All systems need to be evaluated on a continual basis to reduce the risk of errors, make errors more easily recognizable, and provide methods for error mitigation. A simple approach to risk management that may be applied in clinical medicine is discussed.

High-risk behaviour in young men attending sexually transmitted disease clinics in Pune, India

PubMed Central

BRAHME, R. G.; SAHAY, S.; MALHOTRA-KOHLI, R.; DIVEKAR, A. D.; GANGAKHEDKAR, R. R.; PARKHE, A. P.; KHARAT, M. P.; RISBUD, A. R.; BOLLINGER, R. C.; MEHENDALE, S. M.; PARANJAPE, R. S.

2012-01-01

The present study reports sexual risk factors associated with HIV infection among men attending two sexually transmitted disease (STD) clinics in Pune, India and compares these behaviours between young and older men. Between April 1998 and May 2000, 1,872 STD patients were screened for HIV infection. Data on demographics, medical history and sexual behaviour were collected at baseline. The overall HIV prevalence was 22.2%. HIV risk was associated with being divorced or widowed, less educated, living away from the family, having multiple sexual partners and initiation of sex at an early age. The risk behaviours in younger men were different to older men. Younger men were more likely to report early age of initiation of sex, having friends, acquaintances or commercial sex workers as their regular partners, having premarital sex and bisexual orientation. Young men were more educated and reported condom use more frequently compared with the older men. Similar high HIV prevalence among younger and older men highlights the need for focused targeted interventions aimed at adolescents and young men and also appropriate interventions for older men to reduce the risk of HIV and STD acquisition. PMID:15832886

[Curative effect analysis on closed reduction and external fixator under local anesthesia for the treatment of intertrochanteric fracture in elderly patients with high-risk].

PubMed

Wang, Zeng-ping; Liu, Lin; Xue, Wen; Zhou, Hui-ru; Song, Yu-xin; Cai, Li-yang; Cheng, Xian-tang; Qian, Yao-wen

2016-06-01

To explore clinical efficacy of closed reduction and external fixation under local anesthesia for the treatment of high-risk elderly patients with intertrochanteric fracture. From March 2013 to March 2015, 10 patients with intertrochanteric fractures treated with closing reduction and external fixator under local anesthesia were analyszed, including 4 males and 6 females, aged from 69 to 88 years old with an average of 75.2 years old. All fractures were caused by injury and classified to type I (5 cases), II (3 cases), and V (2 cases) according to Evans classification. According to American Society of Anesthesiologists (ASA), 6 cases were type III and 4 cases were type IV. Blood loss,operative time,hospital stays, postoperative complications, ambulation time and fracture healing time were observed, and Harris scoring were used to evaluate hip joint function. All patients were followed up from 3 to 23 months with an average of 13.1 months. One patient with chronic obstructive pulmonary disease died for non-operation reason at 4 months after operation, the other fractures were healed at stage I, the mean fracture healing time was 5.6 months. There were no coxa vara, lower limb venous thrombosis, loosen and remove of needle passage. The average operative time was 46 min, blood loss was (35.00 ± 8.46) ml without blood transfusion. One patient was occurred pulmonary infection and stent-tract infection on the 2 nd and 3 rd day after operation, and improved with active anti-infection and dressing change; the other patients gone to ground activity at 4.2 d after operation. The patients stayed hospital for 10.6 d on average. According to Harris scoring at final following-up, the total score was 83.42 ± 3.27, 3 cases obtained excellent results, 5 cases good and 1 case poor. Closed reduction and external fixation under local anesthesia in treating high-risk elderly patients with intertrochanteric fracture,which has advantages of shorter operative time, less blood loss, good

External beam radiation therapy for clinically localized prostate cancer: when and how we optimize with concurrent hormonal deprivation.

PubMed

Koontz, Bridget F; Lee, W Robert

2011-10-01

Androgen deprivation plays a major role in the treatment of prostate cancer.Preclinical studies have shown that androgen deprivation provides both an independent cytotoxic effect and radiosensitization on prostate tumors. For men with non-metastatic prostate cancer, the addition of androgen deprivation to radiotherapy has been shown to improve survival for intermediate and high risk disease compared to radiation alone.This review discusses the clinical trial data regarding combination of androgen deprivation and radiation and provides recommendations for its use in men undergoing radiotherapy for localized prostate cancer.

The Power Behind the Controversy: Understanding Local Policy Elites' Perceptions on the Benefits and Risks Associated with High Voltage Power Line Installation in the State of Arkansas

NASA Astrophysics Data System (ADS)

Moyer, Rachael M.

Following a proposal for the installation of high voltage power lines in northwest Arkansas, a controversial policy debate emerged. Proponents of the transmission line argue that such an installation is inevitable and necessary to efficiently and reliably support the identified electric load in the region. Opponents claim that the lines will degrade the natural environment and hamper the tourism-based local economy in affected regions, notably in Ozark Mountain areas. This study seeks to understand how local policy elites perceive the benefits and risks associated with proposed transmission lines, which is a critical step in comprehending the formation and changes of related government policies. First, based upon the dual process theory of judgment, this study systematically investigates the triadic relationships between (a) more profound personal value predispositions, (b) affects and feelings, and (c) perceived benefits and risks related to the proposed installation of high voltage power lines among local policy elites in the state of Arkansas. Next, this study focuses more specifically on the role of value predispositions, specific emotional dimensions of affect heuristics, and perceptions pertaining to high voltage power line risks and benefits. Using original data collected from a statewide Internet survey of 420 local leaders and key policymakers about their opinions on the related issues, other factors claimed by previous literature, including trust, knowledge level, and demographic characteristics are considered. Analytical results suggest that grid-group cultural predispositions, as deeply held core values within local policy elites' individual belief systems, both directly and indirectly -- through affective feelings -- shape perceived utility associated with the installation of high voltage power lines. Recognizing that risk perceptions factor into policy decisions, some practical considerations for better designing policy addressing controversial issues

Optimization of prostate biopsy: the role of magnetic resonance imaging targeted biopsy in detection, localization and risk assessment.

PubMed

Bjurlin, Marc A; Meng, Xiaosong; Le Nobin, Julien; Wysock, James S; Lepor, Herbert; Rosenkrantz, Andrew B; Taneja, Samir S

2014-09-01

% in low risk and 71% in high risk patients. In low risk men the negative predictive value of a combination of negative magnetic resonance imaging with prostate volume parameters is nearly 98%, suggesting a potential role in avoiding biopsy and reducing over detection/overtreatment. Among men with a previous negative biopsy 72% to 87% of cancers detected by magnetic resonance imaging guidance are clinically significant. Among men with a known low risk cancer, repeat biopsy using magnetic resonance targeting demonstrates a high likelihood of confirming low risk disease in low suspicion score lesions and of upgrading in high suspicion score lesions. Techniques of magnetic resonance imaging targeted biopsy include visual estimation transrectal ultrasound guided biopsy; software co-registered magnetic resonance imaging-ultrasound, transrectal ultrasound guided biopsy; and in-bore magnetic resonance imaging guided biopsy. Although the improvement in accuracy and efficiency of visual estimation biopsy compared to systematic appears limited, co-registered magnetic resonance imaging-ultrasound biopsy as well as in-bore magnetic resonance imaging guided biopsy appear to increase cancer detection rates in conjunction with increasing suspicion score. Use of magnetic resonance imaging for targeting prostate biopsies has the potential to reduce the sampling error associated with conventional biopsy by providing better disease localization and sampling. More accurate risk stratification through improved cancer sampling may impact therapeutic decision making. Optimal clinical application of magnetic resonance imaging targeted biopsy remains under investigation. Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Effects of relaxation on depression levels in women with high-risk pregnancies: a randomised clinical trial 1

PubMed Central

de Araújo, Wanda Scherrer; Romero, Walckiria Garcia; Zandonade, Eliana; Amorim, Maria Helena Costa

2016-01-01

ABSTRACT Objective: to analyse the effects of relaxation as a nursing intervention on the depression levels of hospitalised women with high-risk pregnancies. Methods: a randomised clinical trial realised in a reference centre for high-risk pregnancies. The sample consisted of 50 women with high-risk pregnancies (25 in the control group and 25 in the intervention group). The Benson relaxation technique was applied to the intervention group for five days. Control variables were collected using a predesigned form, and the signs and symptoms of depression were evaluated using the Edinburgh Postnatal Depression Scale (EPDS). The Statistical Package for Social Sciences (SPSS), version 20.0, was used with a significance level of 5%. The Wilcoxon and paired t-tests were used to evaluate depression levels between two timepoints. Using categorical data, the McNemar test was used to analyse differences in depression severity before and after the intervention. Results: depression levels decreased in the intervention group five days after the relaxation technique was applied (4.5 ± 3, p<0.05) compared with the levels at the first timepoint (10.3±5.9). Conclusion: as a nursing intervention, relaxation was effective in decreasing the symptoms of depression in hospitalised women with high-risk pregnancies. PMID:27627126

High local unemployment rates limit work after lung transplantation.

PubMed

Nau, Michael; Shrider, Emily A; Tobias, Joseph D; Hayes, Don; Tumin, Dmitry

2016-10-01

Most lung transplant (LTx) recipients recover sufficient functional status to resume working, yet unemployment is common after LTx. Weak local labor markets may limit employment opportunities for LTx recipients. United Network for Organ Sharing data on first-time LTx recipients 18-60 years old who underwent transplant between 2010 and 2014 were linked to American Community Survey data on unemployment rates at the ZIP Code level. Multivariable competing-risks regression modeled the influence of dichotomous (≥8%) and continuous local unemployment rates on employment after LTx, accounting for the competing risk of mortality. For comparison, analyses were duplicated in a cohort of heart transplant (HTx) recipients who underwent transplant during the same period. The analysis included 3,897 LTx and 5,577 HTx recipients. Work after LTx was reported by 300 (16.3%) residents of low-unemployment areas and 244 (11.9%) residents of high-unemployment areas (p < 0.001). Multivariable analysis of 3,626 LTx recipients with complete covariate data found that high local unemployment rates limited employment after LTx (sub-hazard ratio = 0.605; 95% confidence interval = 0.477, 0.768; p < 0.001), conditional on not working before transplant. Employment after HTx was higher compared with employment after LTx, and not associated with local unemployment rates in multivariable analyses. LTx recipients of working age exhibit exceptionally low employment rates. High local unemployment rates exacerbate low work participation after LTx, and may discourage job search in this population. Copyright © 2016 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

The Methodology of Clinical Studies Used by the FDA for Approval of High-Risk Orthopaedic Devices.

PubMed

Barker, Jordan P; Simon, Stephen D; Dubin, Jonathan

2017-05-03

The purpose of this investigation was to examine the methodology of clinical trials used by the U.S. Food and Drug Administration (FDA) to determine the safety and effectiveness of high-risk orthopaedic devices approved between 2001 and 2015. Utilizing the FDA's online public database, this systematic review audited study design and methodological variables intended to minimize bias and confounding. An additional analysis of blinding as well as the Checklist to Evaluate a Report of a Nonpharmacological Trial (CLEAR NPT) was applied to the randomized controlled trials (RCTs). Of the 49 studies, 46 (94%) were prospective and 37 (76%) were randomized. Forty-seven (96%) of the studies were controlled in some form. Of 35 studies that reported it, blinding was utilized in 21 (60%), of which 8 (38%) were reported as single-blinded and 13 (62%) were reported as double-blinded. Of the 37 RCTs, outcome assessors were clearly blinded in 6 (16%), whereas 15 (41%) were deemed impossible to blind as implants could be readily discerned on imaging. When the CLEAR NPT was applied to the 37 RCTs, >70% of studies were deemed "unclear" in describing generation of allocation sequences, treatment allocation concealment, and adequate blinding of participants and outcome assessors. This study manifests the highly variable reporting and strength of clinical research methodology accepted by the FDA to approve high-risk orthopaedic devices.

[Studies on localized low-risk prostate cancer : Do we know enough?

PubMed

Weißbach, L; Roloff, C

2018-06-05

Treatment of localized low-risk prostate cancer (PCa) is undergoing a paradigm shift: Invasive treatments such as surgery and radiation therapy are being replaced by defensive strategies such as active surveillance (AS) and watchful waiting (WW). The aim of this work is to evaluate the significance of current studies regarding defensive strategies (AS and WW). The best-known AS studies are critically evaluated for their significance in terms of input criteria, follow-up criteria, and statistical significance. The difficulties faced by randomized studies in answering the question of the best treatment for low-risk cancer in two or even more study groups with known low tumor-specific mortality are clearly shown. Some studies fail because of the objective, others-like PIVOT-are underpowered. ProtecT, a renowned randomized, controlled trial (RCT), lists systematic and statistical shortcomings in detail. The time and effort required for RCTs to answer the question of which therapy is best for locally limited low-risk cancer is very large because the low specific mortality rate requires a large number of participants and a long study duration. In any case, RCTs create hand-picked cohorts for statistical evaluation that have little to do with care in daily clinical practice. The necessary randomization is also offset by the decision-making of the informed patient. If further studies of low-risk PCa are needed, they will need real-world conditions that an RCT can not provide. To obtain clinically relevant results, we need to rethink things: When planning the study, biometricians and clinicians must understand that the statistical methods used in RCTs are of limited use and they must select a method (e.g. propensity scores) appropriate for health care research.

Neuroblastoma: clinical and biological approach to risk stratification and treatment.

PubMed

Tolbert, Vanessa P; Matthay, Katherine K

2018-05-01

Neuroblastoma is the most common extra-cranial solid tumor of childhood and the most common in the first year of life. It is a unique malignancy in that infants often present with either localized or metastatic disease that can spontaneously regress without intervention while older children can succumb to the disease after months to years of arduous therapy. Given this wide range of outcomes, the International Neuroblastoma Risk Group was created to stratify patients based on presenting characteristics and tumor biology in order to guide intensity of treatment strategies. The goal has been to decrease therapy for low-risk patients to avoid long-term complications while augmenting and targeting therapies for high-risk patients to improve overall survival. The international risk stratification depends on age, stage, histology, MYCN gene amplification status, tumor cell ploidy and segmental chromosomal abnormalities. Treatment for asymptomatic low-risk patients with an estimated survival of > 98% is often observation or surgical resection alone, whereas intermediate-risk patients with an estimated survival of > 90% require moderate doses of response-adjusted chemotherapy along with resection. High-risk patients undergo multiple cycles of combination chemotherapy before surgery, followed by consolidation with myeloablative autologous hematopoietic stem cell transplantation and local radiation and finally immunotherapy with differentiation therapy as maintenance phase. With this approach, outcome for patients with neuroblastoma has improved, as the field continues to expand efforts in more targeted therapies for high-risk patients.

Timing of Biochemical Failure and Distant Metastasis for Low, Intermediate, and High Risk Prostate Cancer after Radiotherapy

PubMed Central

Morgan, Peter B.; Hanlon, Alexandra L.; Horwitz, Eric M.; Buyyounouski, Mark K.; Uzzo, Robert G.; Pollack, Alan

2007-01-01

Condensed Abstract The timing of biochemical failure and distant metastasis after radiotherapy for low, intermediate and high-risk prostate cancer was determined. The patterns of failure suggest that the majority of early failures were due to subclinical micrometastases present at diagnosis, whereas a late wave of metastasis at 10–12 years in every risk group was consistent with tumor spread from local persistence of disease. Background The relationship of prostate cancer risk group stratification and the timing of biochemical failure (BF) and distant metastasis (DM) is not well defined. We sought to differentiate early failures due to subclinical micrometastasis at presentation from late failures due to local persistence. Methods A total of 1833 men with clinically localized prostate cancer treated with 3D-conformal radiotherapy with or without short-term androgen deprivation were retrospectively analyzed. The interval hazard rates of DM and BF, using ASTRO and Phoenix (Nadir+2) definitions, were determined for men with low, intermediate, and high risk disease. Results Median follow-up was 67 months. Multivariate analysis showed that increasing risk group was independently associated with higher ASTRO BF (P<.0001) and Nadir+2 BF (P<.0001). The preponderance (87%) of ASTRO BF occurred ≤4 years after RT, while Nadir+2 BF was more evenly spread over years 1–12, with 43% at >4 years. The hazard of Nadir+2 BF persisted in years 8–12 in all risk groups. The interval hazard function for DM appeared to be biphasic (early and late peaks) for intermediate and high risk patients, but no distinct early wave was evident for low risk patients. Conclusions ASTRO BF underestimates late BF due to backdating. Local persistence of disease is suggested by delayed Nadir+2 BF and subsequent late DM in every risk group. The paucity of early DM among those with low risk tumors supports the hypothesis that occult micrometastases contributed to the early wave. PMID:17520705

Adjuvant androgen-deprivation therapy following prostate total cryoablation in high-risk localized prostate cancer patients - Open-labeled randomized clinical trial.

PubMed

Chen, Chung-Hsin; Pu, Yeong-Shiau

2018-06-01

To investigate the efficacy and safety profile of 12-month adjuvant androgen-deprivation therapy (ADT) following total-gland cryoablation (TGC) in patients with high-risk localized prostate cancer (HRLPC). This open-label randomized trial included 38 HRLPC patients who received TGC between July 2011 and March 2013. Within 4 weeks after TGC, subjects were randomly assigned (1:1) to either the 12-month adjuvant ADT or non-adjuvant ADT group. The primary outcome was biochemical failure measured by the Phoenix definition. Adverse events were measured at month 1, 2, 3, 6, 9 and 12. In addition, a cohort of 145 HRLPC patients was selected retrospectively for outcome validation. The adjuvant ADT and non-adjuvant ADT groups did't differ in peri-operative characters, such as age, preoperative PSA, tumor stages, Gleason score, prostate size and cryoprobe number. Four patients with adjuvant ADT withdrew from this trial for personal reasons (N = 2), elevated liver function (N = 1) and poorly controlled hyperglycemia (N = 1). In contrast, none in non-adjuvant ADT group experienced adverse events. Biochemical failures were identified in 5 (26%) patients in each group during a median follow-up duration of 45 months. The median times to biochemical failure were 25 and 5.5 months for adjuvant ADT and non-adjuvant ADT groups, respectively. Biochemical-failure survival curves converged 24 months after TGC. Univariable and multivariable analyses revealed adjuvant ADT was not associated with biochemical recurrences in the validation cohort. Adjuvant ADT does not reduce biochemical failure for HRPLC patients undergoing TGC. It should be further confirmed by a larger cohort. Copyright © 2018. Published by Elsevier Inc.

Phase II multi-institutional clinical trial on a new mixed beam RT scheme of IMRT on pelvis combined with a carbon ion boost for high-risk prostate cancer patients.

PubMed

Marvaso, Giulia; Jereczek-Fossa, Barbara A; Vischioni, Barbara; Ciardo, Delia; Giandini, Tommaso; Hasegawa, Azusa; Cattani, Federica; Carrara, Mauro; Ciocca, Mario; Bedini, Nice; Villa, Sergio; Morlino, Sara; Russo, Stefania; Zerini, Dario; Colangione, Sarah Pia; Panaino, Costanza Maria Vittoria; Fodor, Cristiana; Santoro, Luigi; Pignoli, Emanuele; Valvo, Francesca; Valdagni, Riccardo; De Cobelli, Ottavio; Orecchia, Roberto

2017-05-12

Definition of the optimal treatment schedule for high-risk prostate cancer is under debate. A combination of photon intensity modulated radiotherapy (IMRT) on pelvis with a carbon ion boost might be the optimal treatment scheme to escalate the dose on prostate and deliver curative dose with respect to normal tissue and quality of dose distributions. In fact, carbon ion beams offer the advantage to deliver hypofractionated radiotherapy (RT) using a significantly smaller number of fractions compared to conventional RT without increasing risks of late effects. This study is a prospective phase II clinical trial exploring safety and feasibility of a mixed beam scheme of carbon ion prostate boost followed by photon IMRT on pelvis. The study is designed to enroll 65 patients with localized high-risk prostate cancer at 3 different oncologic hospitals: Istituto Europeo di Oncologia, Fondazione IRCCS Istituto Nazionale dei Tumori, and Centro Nazionale di Adroterapia Oncologica. The primary endpoint is the evaluation of safety and feasibility with acute toxicity scored up to 1 month after the end of RT. Secondary endpoints are treatment early (3 months after the end of RT) and long-term tolerability, quality of life, and efficacy. The study is not yet recruiting; in silico studies are ongoing and we expect to start recruitment by 2017. The present clinical trial aims at improving the current treatment for high-risk prostate cancer, evaluating safety and feasibility of a new RT mixed-beam scheme including photons and carbon ions. Encouraging results are coming from carbon ion facilities worldwide on the treatment of different tumors including prostate cancers. Carbon ions combine physical properties allowing for high dose conformity and advantageous radiobiological characteristics. The proposed mixed beam treatment has the advantage to combine a photon high conformity standard of care IMRT phase with a hypofractionated carbon ion RT boost delivered in a short overall

Early traumatic experiences in those at clinical high risk for psychosis.

PubMed

Addington, Jean; Stowkowy, Jacqueline; Cadenhead, Kristin S; Cornblatt, Barbara A; McGlashan, Thomas H; Perkins, Diana O; Seidman, Larry J; Tsuang, Ming T; Walker, Elaine F; Woods, Scott W; Cannon, Tyrone D

2013-08-01

Several lines of evidence suggest a possible association between a history of trauma in childhood and later psychosis or psychotic-like experiences. The purpose of this study was to determine the extent of childhood trauma and bullying in young people at clinical high risk (CHR) of developing psychosis. The sample consisted of 360 individuals who were at CHR of developing psychosis and 180 age- and gender-matched healthy controls. All participants were assessed on past trauma and bullying. The CHR participants were also assessed on a range of psychopathology and functioning. Individuals at CHR reported significantly more trauma and bullying than healthy controls. Those who had experienced past trauma and bullying were more likely to have increased levels of depression and anxiety and a poorer sense of self. These results offer preliminary support for an association between a history of trauma and later subthreshold symptoms. © 2013 Wiley Publishing Asia Pty Ltd.

The evolving local social contract for managing climate and disaster risk in Vietnam.

PubMed

Christoplos, Ian; Ngoan, Le Duc; Sen, Le Thi Hoa; Huong, Nguyen Thi Thanh; Lindegaard, Lily Salloum

2017-07-01

How do disasters shape local government legitimacy in relation to managing climate- and disaster-related risks? This paper looks at how local authorities in Central Vietnam perceive their social contract for risk reduction, including the partial merging of responsibilities for disaster risk management with new plans for and investments in climate change adaptation and broader socioeconomic development. The findings indicate that extreme floods and storms constitute critical junctures that stimulate genuine institutional change. Local officials are proud of their strengthened role in disaster response and they are eager to boost investment in infrastructure. They have struggled to reinforce their legitimacy among their constituents, but given the shifting roles of the state, private sector, and civil society, and the undiminished emphasis on high-risk development models, their responsibilities for responding to emerging climate change scenarios are increasingly nebulous. The past basis for legitimacy is no longer valid, but tomorrow's social contract is not yet defined. © 2017 The Author(s). Disasters © Overseas Development Institute, 2017.

Impact of Patient Reminders on Papanicolaou Test Completion for High-Risk Patients Identified by a Clinical Decision Support System.

PubMed

MacLaughlin, Kathy L; Kessler, Maya E; Komandur Elayavilli, Ravikumar; Hickey, Branden C; Scheitel, Marianne R; Wagholikar, Kavishwar B; Liu, Hongfang; Kremers, Walter K; Chaudhry, Rajeev

2018-05-01

A clinical decision support system (CDSS) for cervical cancer screening identifies patients due for routine cervical cancer screening. Yet, high-risk patients who require more frequent screening or earlier follow-up to address past abnormal results are not identified. We aimed to assess the effect of a complex CDSS, incorporating national guidelines for high-risk patient screening and abnormal result management, its implementation to identify patients overdue for testing, and the outcome of sending a targeted recommendation for follow-up. At three primary care clinics affiliated with an academic medical center, a reminder recommending an appointment for Papanicolaou (Pap) testing or Pap and human papillomavirus cotesting was sent to high-risk women aged 18 through 65 years (intervention group) identified by CDSS as overdue for testing. Historical control patients, who did not receive a reminder, were identified by CDSS 1 year before the date when reminders were sent to the intervention group. Test completion rates were compared between the intervention and control groups through a generalized estimating equation extension. Across the three sites, the average completion rate of recommended follow-up testing was significantly higher in the intervention group at 23.7% (61/257) than the completion rate at 3.3% (17/516) in the control group (p < 0.001). A CDSS with enhanced capabilities to identify high-risk women due for cervical cancer testing beyond routine screening intervals, with subsequent patient notification, has the potential to decrease cervical precancer and cancer by improving adherence to guideline-compliant follow-up and needed treatment.

A Multigene Expression Assay to Predict Local Recurrence Risk for Ductal Carcinoma In Situ of the Breast

PubMed Central

2013-01-01

Background For women with ductal carcinoma in situ (DCIS) of the breast, the risk of developing an ipsilateral breast event (IBE; defined as local recurrence of DCIS or invasive carcinoma) after surgical excision without radiation is not well defined by clinical and pathologic characteristics. Methods The Oncotype DX breast cancer assay was performed for patients with DCIS treated with surgical excision without radiation in the Eastern Cooperative Oncology Group (ECOG) E5194 study. The association of the prospectively defined DCIS Score (calculated from seven cancer-related genes and five reference genes) with the risk of developing an IBE was analyzed using Cox regression. All statistical tests were two-sided. Results There were 327 patients with adequate tissue for analysis. The continuous DCIS Score was statistically significantly associated with the risk of developing an IBE (hazard ratio [HR] = 2.31, 95% confidence interval [CI] = 1.15 to 4.49; P = .02) when adjusted for tamoxifen use (prespecified primary analysis) and with invasive IBE (unadjusted HR = 3.68, 95% CI = 1.34 to 9.62; P = .01). For the prespecified DCIS risk groups of low, intermediate, and high, the 10-year risks of developing an IBE were 10.6%, 26.7%, and 25.9%, respectively, and for an invasive IBE, 3.7%, 12.3%, and 19.2%, respectively (both log rank P ≤ .006). In multivariable analyses, factors associated with IBE risk were DCIS Score, tumor size, and menopausal status (all P ≤ .02). Conclusions The DCIS Score quantifies IBE risk and invasive IBE risk, complements traditional clinical and pathologic factors, and provides a new clinical tool to improve selecting individualized treatment for women with DCIS who meet the ECOG E5194 criteria. PMID:23641039

Assessing risk of reoffending in adolescents who have committed a sexual offense: the accuracy of clinical judgments after completion of risk assessment instruments.

PubMed

Elkovitch, Natasha; Viljoen, Jodi L; Scalora, Mario J; Ullman, Daniel

2008-01-01

As courts often rely on clinicians when differentiating between sexually abusive youth at a low versus high risk of reoffense, understanding factors that contribute to accuracy in assessment of risk is imperative. The present study built on existing research by examining (1) the accuracy of clinical judgments of risk made after completing risk assessment instruments, (2) whether instrument-informed clinical judgments made with a high degree of confidence are associated with greater accuracy, and (3) the risk assessment instruments and subscales most predictive of clinical judgments. Raters assessed each youth's (n = 166) risk of reoffending after completing the SAVRY and J-SOAP-II. Raters were not able to predict detected cases of either sexual recidivism or nonsexual violent recidivism above chance, and a high degree of rater confidence was not associated with higher levels of accuracy. Total scores on the J-SOAP-II were predictive of instrument-informed clinical judgments of sexual risk, and total scores on the SAVRY of nonsexual risk.

The Subjective Experience of Youths at Clinical High Risk for Psychosis: A Qualitative Study

PubMed Central

Ben-David, Shelly; Birnbaum, Michael; Eilenberg, Mara; DeVylder, Jordan; Gill, Kelly; Schienle, Jessica; Azimov, Neyra; Lukens, Ellen P.; Davidson, Larry; Corcoran, Cheryl Mary

2015-01-01

Objective Understanding the experience of individuals across stages of schizophrenia is important for development of services to promote recovery. As yet, little is known about the experience of individuals who exhibit prodromal symptoms of schizophrenia. Methods Audiotaped interviews were conducted with 27 participants at clinical high risk (CHR) for psychosis (15 males; 12 females; mean age 21; ethnically diverse). Phenomenological qualitative research techniques of coding, consensus, and comparison were used. Results Emergent themes differed by gender. Themes for males were feeling abnormal or “broken”; focus on going “crazy”; fantasy and escapism; and alienation and despair, with a desire for relationships. Themes for females were psychotic illness in family members; personal trauma; struggle with intimate relationships; and career and personal development. Conclusions The finding of relative social engagement and future-orientation of females identified as at risk for psychosis is novel, and has implications for outreach and treatment. PMID:25179420

The subjective experience of youths at clinically high risk of psychosis: a qualitative study.

PubMed

Ben-David, Shelly; Birnbaum, Michael L; Eilenberg, Mara E; DeVylder, Jordan E; Gill, Kelly E; Schienle, Jessica; Azimov, Neyra; Lukens, Ellen P; Davidson, Larry; Corcoran, Cheryl M

2014-12-01

Understanding the experience of individuals across stages of schizophrenia is important for development of services to promote recovery. As yet, little is known about the experience of individuals who exhibit prodromal symptoms of schizophrenia. Audiotaped interviews were conducted with 27 participants of diverse racial-ethnic backgrounds who were at clinically high risk of psychosis (15 males and 12 females; mean age 21). Phenomenological qualitative research techniques of coding, consensus, and comparison were used. Emergent themes differed by gender. Themes for males were feeling abnormal or "broken," focus on going "crazy," fantasy and escapism, and alienation and despair, with a desire for relationships. Themes for females were psychotic illness among family members, personal trauma, struggle with intimate relationships, and career and personal development. The finding of relative social engagement and future orientation of females identified as at risk for psychosis is novel and has implications for outreach and treatment.

Development of a Risk Prediction Model and Clinical Risk Score for Isolated Tricuspid Valve Surgery.

PubMed

LaPar, Damien J; Likosky, Donald S; Zhang, Min; Theurer, Patty; Fonner, C Edwin; Kern, John A; Bolling, Stephen F; Drake, Daniel H; Speir, Alan M; Rich, Jeffrey B; Kron, Irving L; Prager, Richard L; Ailawadi, Gorav

2018-02-01

While tricuspid valve (TV) operations remain associated with high mortality (∼8-10%), no robust prediction models exist to support clinical decision-making. We developed a preoperative clinical risk model with an easily calculable clinical risk score (CRS) to predict mortality and major morbidity after isolated TV surgery. Multi-state Society of Thoracic Surgeons database records were evaluated for 2,050 isolated TV repair and replacement operations for any etiology performed at 50 hospitals (2002-2014). Parsimonious preoperative risk prediction models were developed using multi-level mixed effects regression to estimate mortality and composite major morbidity risk. Model results were utilized to establish a novel CRS for patients undergoing TV operations. Models were evaluated for discrimination and calibration. Operative mortality and composite major morbidity rates were 9% and 42%, respectively. Final regression models performed well (both P<0.001, AUC = 0.74 and 0.76) and included preoperative factors: age, gender, stroke, hemodialysis, ejection fraction, lung disease, NYHA class, reoperation and urgent or emergency status (all P<0.05). A simple CRS from 0-10+ was highly associated (P<0.001) with incremental increases in predicted mortality and major morbidity. Predicted mortality risk ranged from 2%-34% across CRS categories, while predicted major morbidity risk ranged from 13%-71%. Mortality and major morbidity after isolated TV surgery can be predicted using preoperative patient data from the STS Adult Cardiac Database. A simple clinical risk score predicts mortality and major morbidity after isolated TV surgery. This score may facilitate perioperative counseling and identification of suitable patients for TV surgery. Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

"Smong" as local wisdom for disaster risk reduction

NASA Astrophysics Data System (ADS)

Suciani, A.; Islami, Z. R.; Zainal, S.; Sofiyan; Bukhari

2018-04-01

The province of Aceh is located in the northern tip of Sumatera Island, Indonesia, highly vulnerable to the disasters, the so-called earthquakes and Tsunamis. This is due to the geological location of Aceh, which is located where the Indo-Australian and Eurasian plates meet. Many people learned this just after the devastating earthquake and tsunami on December 26, 2004 that killed thousands of people and also caused countless material losses. Before 2004, people in Aceh did not even notice what a tsunami was. Yet, after the earthquake in 2004 which had a magnitude of 9.2, Aceh continues to experience earthquake with magnitudes of 56, just as it did in Pidie Jaya on December 2016. Due to these conditions, the people of Aceh need to be informed of the real and serious threats that these disasters can cause in order to reduce the impact of these potential tragedies. Local wisdom could be an early warning for preventing risk disaster. Local wisdom could be easy to understand, adapt, and use by the society. The purpose of this paper is to publish “Smong” as local wisdom to reduce the risk of potential earthquake and tsunami disasters. The word is referred to Tsunami was adopted from Devayan Language. It is part of the Simeulue indigenous culture, transmitted through songs, short poems, lullabies, and stories. It is fascinating to note that the earthquake and tsunami catastrophe of 2004 resulted in only seven casualties in Simeulue, which has approximately 86.735 inhabitants. Smong is a key word understood by the entire population of Simeulue that describes the occurrence of giant waves after a major earthquake. During the terrible event that plagued Aceh on December 26, 2004, there was a massive evacuation of the entire Simeulue beach area within a few minutes after the earthquake. Therefore, "Smong" is an appropriate term to be used in order to reduce the impact of disasters, viz. earthquakes and tsunamis in high risk areas.

Longitudinal investigation of the relationship between family history of psychosis and affective disorders and Child Behavior Checklist ratings in clinical high-risk adolescents.

PubMed

Simeonova, Diana I; Lee, Frances J; Walker, Elaine F

2015-08-01

This is the first study to investigate whether positive family history (FH) of psychosis and affective disorders moderates the relationship between child diagnostic status and parent-reported social and behavioral problems on the Child Behavior Checklist (CBCL) in clinical high-risk adolescents. This longitudinal investigation assessed 122 participants (mean age=14.25±1.8years) from three groups (at-risk, other personality disorders, non-psychiatric controls) at baseline and one year follow-up. As predicted, there was a main effect of FH for a number of CBCL scales indicating higher scores for adolescents with positive FH. The findings also demonstrate a significant Diagnostic Status×Family History interaction for several behavioral scales providing support for FH as a concurrent and longitudinal moderator of the relationship between diagnostic status and CBCL scales. The moderating effect is present for areas of functioning associated with depression, anxiety, social adjustment, thought problems, attention problems, and aggressive behavior. The findings also indicate that both positive and negative symptoms are related to the genetic vulnerability for developing psychosis in clinical high-risk individuals, particularly those symptoms reflective of emotional, attentional, and interpersonal functioning. The present findings are novel and have significant clinical and research implications. This investigation provides a platform for future studies to clarify further the role of FH in clinical high-risk individuals and contributes to integration of this knowledge in the development of early intervention and prevention approaches in at-risk populations for the emergence of severe mental illness. Copyright © 2015 Elsevier B.V. All rights reserved.

Effect of an enhanced medical home on serious illness and cost of care among high-risk children with chronic illness: a randomized clinical trial.

PubMed

Mosquera, Ricardo A; Avritscher, Elenir B C; Samuels, Cheryl L; Harris, Tomika S; Pedroza, Claudia; Evans, Patricia; Navarro, Fernando; Wootton, Susan H; Pacheco, Susan; Clifton, Guy; Moody, Shade; Franzini, Luisa; Zupancic, John; Tyson, Jon E

Patient-centered medical homes have not been shown to reduce adverse outcomes or costs in adults or children with chronic illness. To assess whether an enhanced medical home providing comprehensive care prevents serious illness (death, intensive care unit [ICU] admission, or hospital stay >7 days) and/or reduces costs among children with chronic illness. Randomized clinical trial of high-risk children with chronic illness (≥3 emergency department visits, ≥2 hospitalizations, or ≥1 pediatric ICU admissions during previous year, and >50% estimated risk for hospitalization) treated at a high-risk clinic at the University of Texas, Houston, and randomized to comprehensive care (n = 105) or usual care (n = 96). Enrollment was between March 2011 and February 2013 (when predefined stopping rules for benefit were met) and outcome evaluations continued through August 31, 2013. Comprehensive care included treatment from primary care clinicians and specialists in the same clinic with multiple features to promote prompt effective care. Usual care was provided locally in private offices or faculty-supervised clinics without modification. Primary outcome: children with a serious illness (death, ICU admission, or hospital stay >7 days), costs (health system perspective). Secondary outcomes: individual serious illnesses, medical services, Medicaid payments, and medical school revenues and costs. In an intent-to-treat analysis, comprehensive care decreased both the rate of children with a serious illness (10 per 100 child-years vs 22 for usual care; rate ratio [RR], 0.45 [95% CI, 0.28-0.73]), and total hospital and clinic costs ($16,523 vs $26,781 per child-year, respectively; cost ratio, 0.58 [95% CI, 0.38-0.88]). In analyses of net monetary benefit, the probability that comprehensive care was cost neutral or cost saving was 97%. Comprehensive care reduced (per 100 child-years) serious illnesses (16 vs 44 for usual care; RR, 0.33 [95% CI, 0.17-0.66]), emergency

Identification of key genes related to high-risk gastrointestinal stromal tumors using bioinformatics analysis.

PubMed

Jin, Shuan; Zhu, Wenhua; Li, Jun

2018-01-01

The purpose of this study was to identify predictive biomarkers used for clinical therapy and prognostic evaluation of high-risk gastrointestinal stromal tumors (GISTs). In this study, microarray data GSE31802 were used to identify differentially expressed genes (DEGs) between high-risk GISTs and low-risk GISTs. Then, enrichment analysis of DEGs was conducted based on the gene ontology and kyoto encyclopedia of genes and genomes pathway database. In addition, the transcription factors and cancer-related genes in DEGs were screened according to the TRANSFAC, TSGene, and TAG database. Finally, protein-protein interaction (PPI) network was constructed and analyzed to look for critical genes involved in high-risk GISTs. A total of forty DEGs were obtained and these genes were mainly involved in four pathways, including melanogenesis, neuroactive ligand-receptor interaction, malaria, and hematopoietic cell lineage. The enriched biological processes were related to the regulation of insulin secretion, integrin activation, and neuropeptide signaling pathway. Transcription factor analysis of DEGs indicated that POU domain, class 2, associating factor 1 (POU2AF1) was significantly downregulated in high-risk GISTs. By constructing the PPI network of DEGs, ten genes with high degrees formed local networks, such as PNOC, P2RY14, and SELP. Four genes as POU2AF1, PNOC, P2RY14, and SELP might be used as biomarkers for prognosis of high-risk GISTs.

Antenatal Care Utilisation and Content between Low-Risk and High-Risk Pregnant Women

PubMed Central

Yeoh, Ping Ling; Hornetz, Klaus; Dahlui, Maznah

2016-01-01

Background The purpose of antenatal care is to monitor and improve the wellbeing of the mother and foetus. The World Health Organization recommends risk-oriented strategy that includes: (i) routine care to all women, (ii) additional care for women with moderately severe diseases and complications, (iii) specialised obstetrical and neonatal care for women with severe diseases and complications. Antenatal care is concerned with adequate care in order to be effective. Measurement for adequacy of antenatal care often applies indexes that assess initiation of care and number of visits. In addition, adequacy of care content should also be assessed. Results of studies in developed settings demonstrate that women without risk factors use antenatal services more frequently than recommended. Such over-utilisation is problematic for low-resourced settings. Moreover, studies show that a substantial proportion of high-risk women had utilisation or content of care below the recommended standard. Yet studies in developing countries have seldom included a comparison between low-risk and high-risk women. The purpose of the study was therefore to assess adequacy of care and pregnancy outcomes for the different risk groups. Methods A retrospective study using a multistage sampling technique, at public-funded primary health care clinics was conducted. Antenatal utilisation level was assessed using a modified Adequacy of Prenatal Care Utilisation index that measures the timing for initiation of care and observed-to-expected visits ratio. Adequacy of antenatal care content assessed compliance to routine care based on the local guidelines. Results Intensive or “adequate-plus” antenatal care utilisation as defined by the modified index was noted in over half of the low-risk women. On the other hand, there were 26% of the high-risk women without the expected intensive utilisation. Primary- or non-educated high-risk women were less likely to have a higher antenatal care utilisation

Percutaneous left ventricular assist device with TandemHeart for high-risk percutaneous coronary intervention: the Mayo Clinic experience.

PubMed

Alli, Oluseun O; Singh, Inder M; Holmes, David R; Pulido, Juan N; Park, Soon J; Rihal, Charanjit S

2012-11-01

In patients with poor left ventricular function and severe left main or multivessel coronary disease, coronary artery bypass grafting (CABG) surgery has been the preferred therapy. However, a number of these patients are either inoperable or poor surgical candidates due to comorbid conditions and previous cardiac surgical procedures. These patients are generally poor candidates for standard percutaneous coronary intervention (PCI) techniques. A hybrid PCI approach with hemodynamic support may be a viable strategy for these patients. We report our experience using the TandemHeart percutaneous left ventricular assist device during high-risk PCI. Retrospective cross-sectional analysis of prospectively collected data in 54 patients undergoing high-risk PCI using the TandemHeart device for support. Hemodynamic and clinical data were collected and analyzed. Baseline clinical characteristics were as follows: mean age 72 ± 1.7 years, males 78%, median ejection fraction 20%, mean serum creatinine 1.6 ± 0.3 2 mg/dL, recent myocardial infarction 52%, COPD 33%, previous CABG 50%, diabetes mellitus 41%, and hypertension 83%. The median SYNTAX score was 33, and the median Jeopardy score was 10. The predicted surgical revascularization mortality was 13% by the Society for Thoracic Surgery risk score and 33% by Euroscore. There was a significant decrease in right and left heart pressures (P < 0.05) with a concomitant increase in the cardiac output from 4.7 to 5.7 L/min (P = 0.03) during TandemHeart support. Left main and multivessel PCI was performed in 62% of patients, and rotablation was used in 48%. Procedural success rate was 97%, whereas 30-day and 6 month survival were 90% and 87%, respectively. Major vascular complications occurred in 13% of cases. None of our patients developed contrast induced nephropathy or needed dialysis. High-risk PCI with percutaneous left ventricular support using TandemHeart is a viable therapeutic strategy for a select subset of patients at very

Local extinction of dragonfly and damselfly populations in low- and high-quality habitat patches.

PubMed

Suhonen, Jukka; Hilli-Lukkarinen, Milla; Korkeamäki, Esa; Kuitunen, Markku; Kullas, Johanna; Penttinen, Jouni; Salmela, Jukka

2010-08-01

Understanding the risk of extinction of a single population is an important problem in both theoretical and applied ecology. Local extinction risk depends on several factors, including population size, demographic or environmental stochasticity, natural catastrophe, or the loss of genetic diversity. The probability of local extinction may also be higher in low-quality sink habitats than in high-quality source habitats. We tested this hypothesis by comparing local extinction rates of 15 species of Odonata (dragonflies and damselflies) between 1930-1975 and 1995-2003 in central Finland. Local extinction rates were higher in low-quality than in high-quality habitats. Nevertheless, for the three most common species there were no differences in extinction rates between low- and high-quality habitats. Our results suggest that a good understanding of habitat quality is crucial for the conservation of species in heterogeneous landscapes.

Differing clinical phenotype for higher alanine-aminotransferase (ALT) compared with high-risk NAFLD fibrosis score in type 2 diabetes mellitus.

PubMed

Williams, Kathryn H; Burns, Kharis; Twigg, Stephen M

2018-03-01

The impact of non-alcoholic fatty liver disease (NAFLD) presence and severity on the diabetes phenotype remains unclear. Our study aimed to explore and contrast the phenotypes associated with higher ALT and high-risk NAFLD fibrosis score (NFS) in type 2 diabetes. 324 patients with type 2 diabetes mellitus who were seen at a diabetes centre for a complications assessment with data for NFS were available for study. Data regarding co-morbidities and pathology were obtained at assessment and by file audit. Logistic regression was used to determine if there were significant relationships between pre-determined diabetes complications and co-morbidities and ALT or high-risk NFS (>0.675). Significant univariate associations with lower ALT included those of osteoporosis/osteopenia and inability to sense the monofilament. High-risk NFS was associated with arrhythmia, VPT ≥ 25 V and albuminuria. The associations of high-risk NFS with albuminuria and VPT ≥ 25 V remained after adjustment. In type 2 diabetes, the clinical phenotype of those with higher ALT is dissimilar, sometimes inverse, to those with high-risk NFS. More emphasis should be placed on liver fibrosis risk rather than on liver enzymes alone. Copyright © 2017. Published by Elsevier Inc.

Perforated Duodenal Ulcer in High Risk Patients: Is Percutaneous Drainage Justified?

PubMed Central

Saber, Aly; Gad, Mohammad A; Ellabban, Gouda M

2012-01-01

Background: Conservative treatment was recommended as the treatment of choice in perforated acute peptic ulcer. Here, we adjunct percutaneous peritoneal drainage with nonoperative conservative treatment in high risk elderly patients with perforated duodenal ulcer. Aim: The work was to study the efficacy of percutaneous peritoneal drainage under local anesthesia supported by conservative measures in high risk elderly patients, according to the American Society of Anesthesiologists grading, with perforated duodenal ulcer. Patients and Methods: Twenty four high risk patients with age >65 years having associated medical illness with evidence of perforated duodenal ulcer. Results: The overall morbidity and mortality were comparable with those treated by conservative measures alone. Conclusion: In high risk patients with perforated peptic ulcer and established peritonitis, percutaneous peritoneal drainage under local anesthesia seems to be effective with least operative trauma and mortality rate. PMID:22393546

Radiofrequency ablation for hepatocellular carcinoma measuring 2 cm or smaller: results and risk factors for local recurrence.

PubMed

Kono, Masashi; Inoue, Tatsuo; Kudo, Masatoshi; Chishina, Hirokazu; Arizumi, Tadaaki; Takita, Masahiro; Kitai, Satoshi; Yada, Norihisa; Hagiwara, Satoru; Minami, Yasunori; Ueshima, Kazuomi; Nishida, Naoshi; Murakami, Takamichi

2014-01-01

The purpose of this study was to evaluate the risk factors for local recurrence with radiofrequency ablation (RFA) for hepatocellular carcinoma (HCC) measuring ≤2 cm. This study involved 234 patients with 274 HCCs measuring ≤2 cm who had undergone RFA as the initial treatment. The mean tumor diameter was 1.478 cm. The median follow-up period was 829 days. We evaluated the post-RFA cumulative local recurrence rate and analyzed the risk factors contributing to clinical outcomes. Cumulative local recurrence rates were 9, 19 and 19% at 1, 2 and 3 years, respectively. Among the 145 cases with a complete safety margin (SM) after RFA, only 4 developed local tumor recurrence and the cumulative rates of local tumor recurrence at 1, 2 and 3 years were 2, 3 and 3%, respectively. Among the 129 cases with incomplete SM, local tumor recurrence developed in 34 and the cumulative rates of local tumor progression at 1, 2 and 3 years were 14, 36 and 36%, respectively. In multivariate analysis, significant risk factors were tumor location (liver surface), irregular gross type and SM <5 mm. Even with HCC measuring ≤2 cm, location and gross type of tumor should be carefully evaluated before RFA is performed.

High risk prescribing in older adults: prevalence, clinical and economic implications and potential for intervention at the population level

PubMed Central

2013-01-01

Background High risk prescribing can compromise independent wellbeing and quality of life in older adults. The aims of this project are to determine the prevalence, risk factors, clinical consequences, and costs of high risk prescribing, and to assess the impact of interventions on high risk prescribing in older people. Methods The proposed project will utilise data from the 45 and Up Study, a large scale cohort of 267,153 men and women aged 45 and over recruited during 2006–2009 from the state of New South Wales, Australia linked to a range of administrative health datasets. High risk prescribing will be assessed using three indicators: polypharmacy (use of five or more medicines); Beers Criteria (an explicit measure of potentially inappropriate medication use); and Drug Burden Index (a pharmacologic dose-dependent measure of cumulative exposure to anticholinergic and sedative medicines). Individual risk factors from the 45 and Up Study questionnaire, and health system characteristics from health datasets that are associated with the likelihood of high risk prescribing will be identified. The main outcome measures will include hospitalisation (first admission to hospital, total days in hospital, cause-specific hospitalisation); admission to institutionalised care; all-cause mortality, and, where possible, cause-specific mortality. Economic costs to the health care system and implications of high risk prescribing will be also investigated. In addition, changes in high risk prescribing will be evaluated in relation to certain routine medicines-related interventions. The statistical analysis will be conducted using standard pharmaco-epidemiological methods including descriptive analysis, univariate and multivariate regression analysis, controlling for relevant confounding factors, using a number of different approaches. Discussion The availability of large-scale data is useful to identify opportunities for improving prescribing, and health in older adults. The size

Risks associated with clinical databases.

PubMed

Eleazar, P Y

1991-11-01

Providers will succeed who are evaluating themselves, and who are continuously striving to examine who they are and where they are going. Conscientious providers know that countless other agencies have them under the microscope and that they have to work to stay ahead in assessing their actions through their clinical database. "Medical care value purchasing" is what every employer and payor is looking for, and providers need to find ways to illustrate cost in relation to quality. The basics of data security and protection should be in place in order to concentrate on the bigger picture. The knowledge of the risk associated with individual hospital databases as well as the risk associated with comparative databases is critical. The hospital-level clinical database is the hub of the wheel. If the risk there can be minimized, the data headed for various investigative sites will have less inherent risk. When it is really recognized and accepted that all financial decisions are made based upon the clinical data generated at the site of care, then data integrity will become a strategic advantage for the industry. Clinical database goals will, over time, cause minimization of risk at all levels. As this occurs, variation in treatment will be explained artfully.

Utilization of small changes in serum creatinine with clinical risk factors to assess the risk of AKI in critically lll adults.

PubMed

Cruz, Dinna N; Ferrer-Nadal, Asunción; Piccinni, Pasquale; Goldstein, Stuart L; Chawla, Lakhmir S; Alessandri, Elisa; Belluomo Anello, Clara; Bohannon, Will; Bove, Tiziana; Brienza, Nicola; Carlini, Mauro; Forfori, Francesco; Garzotto, Francesco; Gramaticopolo, Silvia; Iannuzzi, Michele; Montini, Luca; Pelaia, Paolo; Ronco, Claudio

2014-04-01

Disease biomarkers require appropriate clinical context to be used effectively. Combining clinical risk factors, in addition to small changes in serum creatinine, has been proposed to improve the assessment of AKI. This notion was developed in order to identify the risk of AKI early in a patient's clinical course. We set out to assess the performance of this combination approach. A secondary analysis of data from a prospective multicenter intensive care unit cohort study (September 2009 to April 2010) was performed. Patients at high risk using this combination approach were defined as an early increase in serum creatinine of 0.1-0.4 mg/dl, depending on number of clinical factors predisposing to AKI. AKI was defined and staged using the Acute Kidney Injury Network criteria. The primary outcome was evolution to severe AKI (Acute Kidney Injury Network stages 2 and 3) within 7 days in the intensive care unit. Of 506 patients, 214 (42.2%) patients had early creatinine elevation and were deemed at high risk for AKI. This group was more likely to subsequently develop the primary endpoint (16.4% versus 1.0% [not at high risk], P<0.001). The sensitivity of this grouping for severe AKI was 92%, the specificity was 62%, the positive predictive value was 16%, and the negative predictive value was 99%. After adjustment for Sequential Organ Failure Assessment score, serum creatinine, and hazard tier for AKI, early creatinine elevation remained an independent predictor for severe AKI (adjusted relative risk, 12.86; 95% confidence interval, 3.52 to 46.97). Addition of early creatinine elevation to the best clinical model improved prediction of the primary outcome (area under the receiver operating characteristic curve increased from 0.75 to 0.83, P<0.001). Critically ill patients at high AKI risk, based on the combination of clinical factors and early creatinine elevation, are significantly more likely to develop severe AKI. As initially hypothesized, the high-risk combination

Using risk-adjustment models to identify high-cost risks.

PubMed

Meenan, Richard T; Goodman, Michael J; Fishman, Paul A; Hornbrook, Mark C; O'Keeffe-Rosetti, Maureen C; Bachman, Donald J

2003-11-01

We examine the ability of various publicly available risk models to identify high-cost individuals and enrollee groups using multi-HMO administrative data. Five risk-adjustment models (the Global Risk-Adjustment Model [GRAM], Diagnostic Cost Groups [DCGs], Adjusted Clinical Groups [ACGs], RxRisk, and Prior-expense) were estimated on a multi-HMO administrative data set of 1.5 million individual-level observations for 1995-1996. Models produced distributions of individual-level annual expense forecasts for comparison to actual values. Prespecified "high-cost" thresholds were set within each distribution. The area under the receiver operating characteristic curve (AUC) for "high-cost" prevalences of 1% and 0.5% was calculated, as was the proportion of "high-cost" dollars correctly identified. Results are based on a separate 106,000-observation validation dataset. For "high-cost" prevalence targets of 1% and 0.5%, ACGs, DCGs, GRAM, and Prior-expense are very comparable in overall discrimination (AUCs, 0.83-0.86). Given a 0.5% prevalence target and a 0.5% prediction threshold, DCGs, GRAM, and Prior-expense captured $963,000 (approximately 3%) more "high-cost" sample dollars than other models. DCGs captured the most "high-cost" dollars among enrollees with asthma, diabetes, and depression; predictive performance among demographic groups (Medicaid members, members over 64, and children under 13) varied across models. Risk models can efficiently identify enrollees who are likely to generate future high costs and who could benefit from case management. The dollar value of improved prediction performance of the most accurate risk models should be meaningful to decision-makers and encourage their broader use for identifying high costs.

High-Intensity Focused Ultrasound (HIFU) Using Sonablate® Devices for the Treatment of Benign Prostatic Hyperplasia and Localized Prostate Cancer: 18-year experience

NASA Astrophysics Data System (ADS)

Uchida, Toyoaki

2011-09-01

From 1993 to 2010, we have treated 156 patients benign prostatic hyperplasia (BPH) and 1,052 patients localized prostate cancer high-intensity focused ultrasound (HIFU). Four different HIFU devices, SonablateR-200, SonablateR-500, SonablateR-500 version 4 and Sonablate® TCM, have been used for this study. Clinical outcome of HIFU for BPH did not show any superior effects to transurethral resection of the prostate, laser surgery or transurethral vapolization of the prostate. However, HIFU appears to be a safe and minimally invasive therapy for patients with localized prostate cancer, especially low- and intermediate-risk patients. The rate of clinical outcome has significantly improved over the years due to technical improvements in the device.

Clinical Validity, Understandability, and Actionability of Online Cardiovascular Disease Risk Calculators: Systematic Review.

PubMed

Bonner, Carissa; Fajardo, Michael Anthony; Hui, Samuel; Stubbs, Renee; Trevena, Lyndal

2018-02-01

Online health information is particularly important for cardiovascular disease (CVD) prevention, where lifestyle changes are recommended until risk becomes high enough to warrant pharmacological intervention. Online information is abundant, but the quality is often poor and many people do not have adequate health literacy to access, understand, and use it effectively. This project aimed to review and evaluate the suitability of online CVD risk calculators for use by low health literate consumers in terms of clinical validity, understandability, and actionability. This systematic review of public websites from August to November 2016 used evaluation of clinical validity based on a high-risk patient profile and assessment of understandability and actionability using Patient Education Material Evaluation Tool for Print Materials. A total of 67 unique webpages and 73 unique CVD risk calculators were identified. The same high-risk patient profile produced widely variable CVD risk estimates, ranging from as little as 3% to as high as a 43% risk of a CVD event over the next 10 years. One-quarter (25%) of risk calculators did not specify what model these estimates were based on. The most common clinical model was Framingham (44%), and most calculators (77%) provided a 10-year CVD risk estimate. The calculators scored moderately on understandability (mean score 64%) and poorly on actionability (mean score 19%). The absolute percentage risk was stated in most (but not all) calculators (79%), and only 18% included graphical formats consistent with recommended risk communication guidelines. There is a plethora of online CVD risk calculators available, but they are not readily understandable and their actionability is poor. Entering the same clinical information produces widely varying results with little explanation. Developers need to address actionability as well as clinical validity and understandability to improve usefulness to consumers with low health literacy. �

High-Intensity Focused Ultrasound (HIFU) in Localized Prostate Cancer Treatment.

PubMed

Alkhorayef, Mohammed; Mahmoud, Mustafa Z; Alzimami, Khalid S; Sulieman, Abdelmoneim; Fagiri, Maram A

2015-01-01

High-intensity focused ultrasound (HIFU) applies high-intensity focused ultrasound energy to locally heat and destroy diseased or damaged tissue through ablation. This study intended to review HIFU to explain the fundamentals of HIFU, evaluate the evidence concerning the role of HIFU in the treatment of prostate cancer (PC), review the technologies used to perform HIFU and the published clinical literature regarding the procedure as a primary treatment for PC. Studies addressing HIFU in localized PC were identified in a search of internet scientific databases. The analysis of outcomes was limited to journal articles written in English and published between 2000 and 2013. HIFU is a non-invasive approach that uses a precisely delivered ultrasound energy to achieve tumor cell necrosis without radiation or surgical excision. In current urological oncology, HIFU is used clinically in the treatment of PC. Clinical research on HIFU therapy for localized PC began in the 1990s, and the majority of PC patients were treated with the Ablatherm device. HIFU treatment for localized PC can be considered as an alternative minimally invasive therapeutic modality for patients who are not candidates for radical prostatectomy. Patients with lower pre-HIFU PSA level and favourable pathologic Gleason score seem to present better oncologic outcomes. Future advances in technology and safety will undoubtedly expand the HIFU role in this indication as more of patient series are published, with a longer follow-up period.

High-Intensity Focused Ultrasound (HIFU) in Localized Prostate Cancer Treatment

PubMed Central

Alkhorayef, Mohammed; Mahmoud, Mustafa Z.; Alzimami, Khalid S.; Sulieman, Abdelmoneim; Fagiri, Maram A.

2015-01-01

Summary Background High-intensity focused ultrasound (HIFU) applies high-intensity focused ultrasound energy to locally heat and destroy diseased or damaged tissue through ablation. This study intended to review HIFU to explain the fundamentals of HIFU, evaluate the evidence concerning the role of HIFU in the treatment of prostate cancer (PC), review the technologies used to perform HIFU and the published clinical literature regarding the procedure as a primary treatment for PC. Material/Methods Studies addressing HIFU in localized PC were identified in a search of internet scientific databases. The analysis of outcomes was limited to journal articles written in English and published between 2000 and 2013. Results HIFU is a non-invasive approach that uses a precisely delivered ultrasound energy to achieve tumor cell necrosis without radiation or surgical excision. In current urological oncology, HIFU is used clinically in the treatment of PC. Clinical research on HIFU therapy for localized PC began in the 1990s, and the majority of PC patients were treated with the Ablatherm device. Conclusions HIFU treatment for localized PC can be considered as an alternative minimally invasive therapeutic modality for patients who are not candidates for radical prostatectomy. Patients with lower pre-HIFU PSA level and favourable pathologic Gleason score seem to present better oncologic outcomes. Future advances in technology and safety will undoubtedly expand the HIFU role in this indication as more of patient series are published, with a longer follow-up period. PMID:25806099

Clinical outcomes and cost-effectiveness of strategies for managing people at high risk for diabetes.

PubMed

Eddy, David M; Schlessinger, Leonard; Kahn, Richard

2005-08-16

Lifestyle modification can forestall diabetes in high-risk people, but the long-term cost-effectiveness is uncertain. To estimate the effects of the lifestyle modification program used in the Diabetes Prevention Program (DPP) on health and economic outcomes. Cost-effectiveness analysis using the Archimedes model. Published basic and epidemiologic studies, clinical trials, and Kaiser Permanente administrative data. Adults at high risk for diabetes (body mass index >24 kg/m2, fasting plasma glucose level of 5.2725 to 6.9375 mmol/L [95 to 125 mg/dL], 2-hour glucose tolerance test result of 7.77 to 11.0445 mmol/L [140 to 199 mg/dL]). 5 to 30 years. Patient, health plan, and societal. No prevention, DPP's lifestyle modification program, lifestyle modification begun after a person develops diabetes, and metformin. Diagnosis and complications of diabetes. Compared with no prevention program, the DPP lifestyle program would reduce a high-risk person's 30-year chances of getting diabetes from about 72% to 61%, the chances of a serious complication from about 38% to 30%, and the chances of dying of a complication of diabetes from about 13.5% to 11.2%. Metformin would deliver about one third the long-term health benefits achievable by immediate lifestyle modification. Compared with not implementing any prevention program, the expected 30-year cost/quality-adjusted life-year (QALY) of the DPP lifestyle intervention from the health plan's perspective would be about 143,000 dollars. From a societal perspective, the cost/QALY of the lifestyle intervention compared with doing nothing would be about 62,600 dollars. Either using metformin or delaying the lifestyle intervention until after a person develops diabetes would be more cost-effective, costing about 35,400 dollars or 24,500 dollars per QALY gained, respectively, compared with no program. Compared with delaying the lifestyle program until after diabetes is diagnosed, the marginal cost-effectiveness of beginning the DPP

High-risk PCI: how to define it today?

PubMed

DE Marzo, Vincenzo; D'Amario, Domenico; Galli, Mattia; Vergallo, Rocco; Porto, Italo

2018-04-11

Before the percutaneous spread, the mortality rate of patients with coronary heart disease not suitable for cardiac surgery was markedly high. This limit has been progressively exceeded with the advent of minimally invasive approaches, which, although was initially intended exclusively for low risk patients, was then employed in complex patients often too compromised to undergo cardiac surgery. Given to the rising of high-risk population, due to an increase of patients with multiple chronic conditions linked to the best care offered, we are witnessing an expansion of the high-risk percutaneous coronary interventions (PCI) population. Despite defining what high-risk is remains still unclear, all proposed definitions of high-risk PCI combine features related to three clinical areas: 1) patient risk factors and comorbidities (incorporating those which preclude surgical or percutaneous revascularization such as diabetes, COPD, CKD, lung disease, frailty, advanced age); 2) location of the disease and complexity of coronary anatomy (including multi-vessel disease, left main disease, CTO, bifurcations); 3) hemodynamic clinical status (ventricular dysfunction, concomitant valvular disease or unstable characteristics). Since cardiologists have ascertained the encouraging results in terms of efficacy and rewards compared to the low-risks patients, the important role of treating high-risk patients is becoming more and more relevant to the point that current guidelines have now changed the appropriateness of percutaneous interventions indications. Considering the complexity in managing higher-risk patients with coronary artery disease, the next step to ensure the best care for this type of patients is to create a team-based model of cooperation in order to properly establish the right treatment for the right patient.

Prevalence and predictors of Lymphogranuloma venereum in a high risk population attending a STD outpatients clinic in Italy.

PubMed

Foschi, Claudio; Marangoni, Antonella; D'Antuono, Antonietta; Nardini, Paola; Compri, Monica; Bellavista, Sara; Filippini, Andrea; Bacchi Reggiani, Maria Letizia; Cevenini, Roberto

2014-04-09

We evaluated LGV prevalence and predictors in a high risk population attending a STI Outpatients Clinic in the North of Italy. A total of 108 patients (99 MSM and 9 women), with a history of unsafe anal sexual intercourses, were enrolled. Anorectal swabs and urine samples were tested for Chlamydia trachomatis (CT) DNA detection by Versant CT/GC DNA 1.0 Assay (Siemens Healthcare Diagnostics Terrytown, USA). RFLP analysis was used for CT molecular typing. L2 CT genotype was identified in 13/108 (12%) rectal swabs. All LGV cases were from MSM, declaring high-risk sexual behaviour and complaining anorectal symptoms. Patients first attending the STI Outpatient Clinic received a significant earlier LGV diagnosis than those first seeking care from general practitioners or gastroenterologists (P = 0.0046). LGV prevalence and characteristics found in our population are in agreement with international reports. Statistical analysis showed that LGV positive patients were older (P = 0.0008) and presented more STIs (P = 0.0023) than LGV negative ones, in particular due to syphilis (P < 0.001), HIV (P < 0.001) and HBV (P = 0.001).Multivariate logistic regression analysis revealed that HIV and syphilis infections are strong risk factors for LGV presence (respectively, P = 0.001 and P = 0.010). Even if our results do not provide sufficient evidence to recommend routine screening of anorectal swabs in high-risk population, they strongly suggest to perform CT NAAT tests and genotyping on rectal specimens in presence of ulcerative proctitis in HIV and/or syphilis-positive MSM. In this context, CT DNA detection by Versant CT/GC DNA 1.0 Assay, followed by RFLP analysis for molecular typing demonstrated to be an excellent diagnostic algorithm for LGV identification.

Clinical dysphagia risk predictors after prolonged orotracheal intubation.

PubMed

Medeiros, Gisele Chagas de; Sassi, Fernanda Chiarion; Mangilli, Laura Davison; Zilberstein, Bruno; Andrade, Claudia Regina Furquim de

2014-01-01

To elucidate independent risk factors for dysphagia after prolonged orotracheal intubation. The participants were 148 consecutive patients who underwent clinical bedside swallowing assessments from September 2009 to September 2011. All patients had received prolonged orotracheal intubations and were admitted to one of several intensive care units of a large Brazilian school hospital. The correlations between the conducted water swallow test results and dysphagia risk levels were analyzed for statistical significance. Of the 148 patients included in the study, 91 were male and 57 were female (mean age, 53.64 years). The univariate analysis results indicated that specific variables, including extraoral loss, multiple swallows, cervical auscultation, vocal quality, cough, choking, and other signs, were possible significant high-risk indicators of dysphagia onset. The multivariate analysis results indicated that cervical auscultation and coughing were independent predictive variables for high dysphagia risk. Patients displaying extraoral loss, multiple swallows, cervical auscultation, vocal quality, cough, choking and other signs should benefit from early swallowing evaluations. Additionally, early post-extubation dysfunction recognition is paramount in reducing the morbidity rate in this high-risk population.

Association of insertion-deletions polymorphisms with colorectal cancer risk and clinical features

PubMed Central

Marques, Diego; Ferreira-Costa, Layse Raynara; Ferreira-Costa, Lorenna Larissa; Correa, Romualdo da Silva; Borges, Aline Maciel Pinheiro; Ito, Fernanda Ribeiro; Ramos, Carlos Cesar de Oliveira; Bortolin, Raul Hernandes; Luchessi, André Ducati; Ribeiro-dos-Santos, Ândrea; Santos, Sidney; Silbiger, Vivian Nogueira

2017-01-01

AIM To investigate the association between 16 insertion-deletions (INDEL) polymorphisms, colorectal cancer (CRC) risk and clinical features in an admixed population. METHODS One hundred and forty patients with CRC and 140 cancer-free subjects were examined. Genomic DNA was extracted from peripheral blood samples. Polymorphisms and genomic ancestry distribution were assayed by Multiplex-PCR reaction, separated by capillary electrophoresis on the ABI 3130 Genetic Analyzer instrument and analyzed on GeneMapper ID v3.2. Clinicopathological data were obtained by consulting the patients’ clinical charts, intra-operative documentation, and pathology scoring. RESULTS Logistic regression analysis showed that polymorphism variations in IL4 gene was associated with increased CRC risk, while TYMS and UCP2 genes were associated with decreased risk. Reference to anatomical localization of tumor Del allele of NFKB1 and CASP8 were associated with more colon related incidents than rectosigmoid. In relation to the INDEL association with tumor node metastasis (TNM) stage risk, the Ins alleles of ACE, HLAG and TP53 (6 bp INDEL) were associated with higher TNM stage. Furthermore, regarding INDEL association with relapse risk, the Ins alleles of ACE, HLAG, and UGT1A1 were associated with early relapse risk, as well as the Del allele of TYMS. Regarding INDEL association with death risk before 10 years, the Ins allele of SGSM3 and UGT1A1 were associated with death risk. CONCLUSION The INDEL variations in ACE, UCP2, TYMS, IL4, NFKB1, CASP8, TP53, HLAG, UGT1A1, and SGSM3 were associated with CRC risk and clinical features in an admixed population. These data suggest that this cancer panel might be useful as a complementary tool for better clinical management, and more studies need to be conducted to confirm these findings. PMID:29085228

Association of insertion-deletions polymorphisms with colorectal cancer risk and clinical features.

PubMed

Marques, Diego; Ferreira-Costa, Layse Raynara; Ferreira-Costa, Lorenna Larissa; Correa, Romualdo da Silva; Borges, Aline Maciel Pinheiro; Ito, Fernanda Ribeiro; Ramos, Carlos Cesar de Oliveira; Bortolin, Raul Hernandes; Luchessi, André Ducati; Ribeiro-Dos-Santos, Ândrea; Santos, Sidney; Silbiger, Vivian Nogueira

2017-10-07

To investigate the association between 16 insertion-deletions (INDEL) polymorphisms, colorectal cancer (CRC) risk and clinical features in an admixed population. One hundred and forty patients with CRC and 140 cancer-free subjects were examined. Genomic DNA was extracted from peripheral blood samples. Polymorphisms and genomic ancestry distribution were assayed by Multiplex-PCR reaction, separated by capillary electrophoresis on the ABI 3130 Genetic Analyzer instrument and analyzed on GeneMapper ID v3.2. Clinicopathological data were obtained by consulting the patients' clinical charts, intra-operative documentation, and pathology scoring. Logistic regression analysis showed that polymorphism variations in IL4 gene was associated with increased CRC risk, while TYMS and UCP2 genes were associated with decreased risk. Reference to anatomical localization of tumor Del allele of NFKB1 and CASP8 were associated with more colon related incidents than rectosigmoid. In relation to the INDEL association with tumor node metastasis (TNM) stage risk, the Ins alleles of ACE , HLAG and TP53 (6 bp INDEL) were associated with higher TNM stage. Furthermore, regarding INDEL association with relapse risk, the Ins alleles of ACE , HLAG , and UGT1A1 were associated with early relapse risk, as well as the Del allele of TYMS . Regarding INDEL association with death risk before 10 years, the Ins allele of SGSM3 and UGT1A1 were associated with death risk. The INDEL variations in ACE , UCP2 , TYMS , IL4 , NFKB1 , CASP8 , TP53 , HLAG , UGT1A1 , and SGSM3 were associated with CRC risk and clinical features in an admixed population. These data suggest that this cancer panel might be useful as a complementary tool for better clinical management, and more studies need to be conducted to confirm these findings.

Risk factors and predictive clinical scores for asthma exacerbations in childhood.

PubMed

Forno, Erick; Fuhlbrigge, Anne; Soto-Quirós, Manuel E; Avila, Lydiana; Raby, Benjamin A; Brehm, John; Sylvia, Jody M; Weiss, Scott T; Celedón, Juan C

2010-11-01

Asthma is a major public health problem that affects millions of children worldwide, and exacerbations account for most of its morbidity and costs. Primary-care providers lack efficient tools to identify children at high risk for exacerbations. We aimed to construct a clinical score to help providers to identify such children. Our main outcome was severe asthma exacerbation, which was defined as any hospitalization, urgent visit, or systemic steroid course for asthma in the previous year, in children. A clinical score, consisting of a checklist questionnaire made up of 17 yes-no questions regarding asthma symptoms, use of medications and health-care services, and history, was built and validated in a cross-sectional study of Costa Rican children with asthma. It was then evaluated using data from the Childhood Asthma Management Program (CAMP), a longitudinal trial cohort of North American children. Compared with children at average risk for an exacerbation in the Costa Rican validation set, the odds of an exacerbation among children in the low-risk (OR, 0.2; 95% CI, 0.1-0.4) and high-risk (OR, 5.4; 95% CI, 1.5-19.2) score categories were significantly reduced and increased, respectively. In CAMP, the hazard ratios for an exacerbation after 1-year follow-up in the low-risk and high-risk groups were 0.6 (95% CI, 0.5-0.7) and 1.9 (95% CI, 1.4-2.4), respectively, with similar results at 2 years. The proposed Asthma Exacerbation Clinical Score is simple to use and effective at identifying children at high and low risk for asthma exacerbations. The tool can easily be used in primary-care settings.

[Nutritional risk screening and its clinical significance in 706 children hospitalized in the surgical department].

PubMed

Peng, Lu-Ting; Li, Rong; Zhao, Wei-Hua; Chen, Yin-Hua; Li, Xiao-Mei; Chen, Meng-Ying; Cao, Jia; Li, Xiao-Nan

2013-10-01

To investigate nutritional risk and its relationship with clinical outcome in children hospitalized in the surgical department, and to provide a scientific basis for clinical nutrition management. Nutritional risk screening was performed on 706 children hospitalized in the surgical department using the Screening Tool for Risk on Nutritional Status and Growth. The data on nutritional support during hospitalization, incidence of infectious complications, length of hospital stay, post operative length of hospital stay and total hospital expenses were recorded. Of the 706 cases, 11.5% had high nutritional risk, 46.0% had moderate nutritional risk, and 42.5% had low nutritional risk. Congenital hypertrophic pyloric stenosis, intestinal obstruction and congenital heart disease were the three most common types of high nutritional risk. The incidence of high nutritional risk was significantly higher in infants than in other age groups (P<0.01). Fifty-two (64.2%) of the eighty-one children with high nutritional risk received parenteral nutrition. Children with high nutritional risk were significantly more likely to have weight loss than children with low nutritional risk (P<0.05). Children with high nutritional risk had significantly increased incidence of infectious complications, length of hospital stay, post operative length of hospital stay and total hospital expenses compared with those with moderate or low nutritional risk (P<0.01). Moderate or high nutritional risk is seen in children hospitalized in the surgical department. Nutritional risk score is correlated with clinical outcome. Nutritional support for these children is not yet properly provided. Nutritional risk screening and standard nutritional support should be widely applied among hospitalized children.

Maximizing retention with high risk participants in a clinical trial.

PubMed

Kim, Romina; Hickman, Norval; Gali, Kathleen; Orozco, Nicholas; Prochaska, Judith J

2014-01-01

To describe effective retention strategies in a clinical trial with a high risk, low-income, and vulnerable patient population with serious mental illness. Follow-up assessments were conducted for a randomized clinical tobacco treatment trial at 3, 6, and 12 months postbaseline. Initial follow-up rates of <40% at 3 months led to implementation of proactive retention strategies including obtaining extensive contact information; building relationships with case managers and social workers; contacting jails and prisons; text messaging, e-mailing, and messaging via social networking sites; identifying appointments via electronic medical record; and field outreach to treatment facilities, residences, and parks. Large urban public hospital. Participants were current smokers recruited from 100% smoke-free locked psychiatry units. Assessments covered demographics, substance use, and mental health functioning. Retention rates were plotted over time in relation to key retention strategies. Chi-square and t-tests were used to examine participant predictors of retention at each follow-up. At the 12-month follow-up, the retention strategies that most frequently led to assessment completion were identified. The sample (N = 100) was 65% male; age x = 39.5 years (SD = 11.3); 44% non-Hispanic white; 46% on Medicaid and 34% uninsured; 79% unemployed; and 48% unstably housed. Proactive retention strategies dramatically increased follow-up rates, concluding at 3 months = 82.65%, 6 months = 89.69%, and 12 months = 92.78%. Married and divorced/separated/widowed participants, those with higher income, and participants with alcohol or illicit drug problems had increased retention from 3- to 12-month follow-up. Follow-up rates improved as proactive methods to contact participants were implemented. Dedicated research staff, multiple methods, community networking, and outreach within drug treatment settings improved retention.

The Dark Side of the Moon: Meta-analytical Impact of Recruitment Strategies on Risk Enrichment in the Clinical High Risk State for Psychosis

PubMed Central

Fusar-Poli, Paolo; Schultze-Lutter, Frauke; Cappucciati, Marco; Rutigliano, Grazia; Bonoldi, Ilaria; Stahl, Daniel; Borgwardt, Stephan; Riecher-Rössler, Anita; Addington, Jean; Perkins, Diana O.; Woods, Scott W.; McGlashan, Thomas; Lee, Jimmy; Klosterkötter, Joachim; Yung, Alison R.; McGuire, Philip

2016-01-01

Background: The individual risk of developing psychosis after being tested for clinical high-risk (CHR) criteria (posttest risk of psychosis) depends on the underlying risk of the disease of the population from which the person is selected (pretest risk of psychosis), and thus on recruitment strategies. Yet, the impact of recruitment strategies on pretest risk of psychosis is unknown. Methods: Meta-analysis of the pretest risk of psychosis in help-seeking patients selected to undergo CHR assessment: total transitions to psychosis over the pool of patients assessed for potential risk and deemed at risk (CHR+) or not at risk (CHR−). Recruitment strategies (number of outreach activities per study, main target of outreach campaign, and proportion of self-referrals) were the moderators examined in meta-regressions. Results: 11 independent studies met the inclusion criteria, for a total of 2519 (CHR+: n = 1359; CHR−: n = 1160) help-seeking patients undergoing CHR assessment (mean follow-up: 38 months). The overall meta-analytical pretest risk for psychosis in help-seeking patients was 15%, with high heterogeneity (95% CI: 9%–24%, I 2 = 96, P < .001). Recruitment strategies were heterogeneous and opportunistic. Heterogeneity was largely explained by intensive (n = 11, β = −.166, Q = 9.441, P = .002) outreach campaigns primarily targeting the general public (n = 11, β = −1.15, Q = 21.35, P < .001) along with higher proportions of self-referrals (n = 10, β = −.029, Q = 4.262, P = .039), which diluted pretest risk for psychosis in patients undergoing CHR assessment. Conclusions: There is meta-analytical evidence for overall risk enrichment (pretest risk for psychosis at 38monhts = 15%) in help-seeking samples selected for CHR assessment as compared to the general population (pretest risk of psychosis at 38monhts=0.1%). Intensive outreach campaigns predominantly targeting the general population and a higher proportion of self-referrals diluted the pretest risk

The Dark Side of the Moon: Meta-analytical Impact of Recruitment Strategies on Risk Enrichment in the Clinical High Risk State for Psychosis.

PubMed

Fusar-Poli, Paolo; Schultze-Lutter, Frauke; Cappucciati, Marco; Rutigliano, Grazia; Bonoldi, Ilaria; Stahl, Daniel; Borgwardt, Stephan; Riecher-Rössler, Anita; Addington, Jean; Perkins, Diana O; Woods, Scott W; McGlashan, Thomas; Lee, Jimmy; Klosterkötter, Joachim; Yung, Alison R; McGuire, Philip

2016-05-01

The individual risk of developing psychosis after being tested for clinical high-risk (CHR) criteria (posttest risk of psychosis) depends on the underlying risk of the disease of the population from which the person is selected (pretest risk of psychosis), and thus on recruitment strategies. Yet, the impact of recruitment strategies on pretest risk of psychosis is unknown. Meta-analysis of the pretest risk of psychosis in help-seeking patients selected to undergo CHR assessment: total transitions to psychosis over the pool of patients assessed for potential risk and deemed at risk (CHR+) or not at risk (CHR-). Recruitment strategies (number of outreach activities per study, main target of outreach campaign, and proportion of self-referrals) were the moderators examined in meta-regressions. 11 independent studies met the inclusion criteria, for a total of 2519 (CHR+: n = 1359; CHR-: n = 1160) help-seeking patients undergoing CHR assessment (mean follow-up: 38 months). The overall meta-analytical pretest risk for psychosis in help-seeking patients was 15%, with high heterogeneity (95% CI: 9%-24%, I (2) = 96, P < .001). Recruitment strategies were heterogeneous and opportunistic. Heterogeneity was largely explained by intensive (n = 11, β = -.166, Q = 9.441, P = .002) outreach campaigns primarily targeting the general public (n = 11, β = -1.15, Q = 21.35, P < .001) along with higher proportions of self-referrals (n = 10, β = -.029, Q = 4.262, P = .039), which diluted pretest risk for psychosis in patients undergoing CHR assessment. There is meta-analytical evidence for overall risk enrichment (pretest risk for psychosis at 38 monhts = 15%) in help-seeking samples selected for CHR assessment as compared to the general population (pretest risk of psychosis at 38 monhts=0.1%). Intensive outreach campaigns predominantly targeting the general population and a higher proportion of self-referrals diluted the pretest risk for psychosis. © The Author 2015. Published by

Localized Scleroderma: A Clinical Review.

PubMed

Tratenberg, Mark; Gutwein, Farrah; Rao, Varuni; Sperber, Kirk; Wasserrman, Amy; Ash, Julia

2017-01-01

Localized scleroderma (LS) is characterized by excessive collagen deposition leading to thickening of the dermis, subcutaneous tissue or both. The outcome for most patients with localized scleroderma is directly related to the type and stage of the affected tissue. The major challenge for untreated patients is not increased mortality risk, rather deformity and growth defects from skin, muscle and bone abnormalities. Treatment is individualized to type and stage of the lesion and may include pharmacologic and non-pharmacologic therapies. Among the pharmacologic modalities, methotrexate with systemic glucocorticoids is currently the mainstay of treatment. More controlled trials are needed to determine the length of treatment and the maintenance dose of this combination therapy. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Prenatal High Risk Scoring: How Family Doctors Do It

PubMed Central

Shea, Philip

1978-01-01

Assessment of risk factors is an integral part of family medicine and of prenatal care. A strong positive relationship has been demonstrated between a high risk score and higher incidence of maternal or perinatal morbidity and mortality. The family physician, because of his previous knowledge of the patient, and his familiarity with a broad range of normals, is in a good position to use his clinical judgement in high risk scoring in pregnancy. We must also be cautious that high risk scoring does not become a self fulfilling prophecy. Risk scoring is simply risk scoring, not a plan of management and intervention. PMID:21301562

Practice-Based Research Network Infrastructure Design for Institutional Review Board Risk Assessment and Generalizability of Clinical Results.

PubMed

Curro, Frederick; Thompson, Van P; Naftolin, Frederick; Grill, Ashley; Vena, Don; Terracio, Louis; Hashimoto, Mariko; Buchholz, Matthew; McKinstry, Andrea; Cannon, Diane; Alfano, Vincent; Gooden, Thalia; Vernillo, Anthony; Czeisler, Elan

2013-01-01

Data from clinical studies generated by Practice Based Research Networks should be generalizable to the profession. For nationally representative data a broad recruitment of practitioners may pose added risks to IRB's. Infrastructure must assure data integrity while minimizing risk to assure that the clinical results are generalizable. The PEARL Network is an interdisciplinary dental/medical PBRN conducting a broad range of clinical studies. The infrastructure is designed to support the principles of Good Clinical Practice (GCP) and create a data audit trail to ensure data integrity for generalizability. As the PBRN concept becomes of greater interest, membership may expand beyond the local community, and the issue of geography versus risk management becomes of concern to the IRB. The PEARL Network describes how it resolves many of the issues related to recruiting on a National basis while maintaining study compliance to ensure patient safety and minimize risk to the IRB.

Psychosis prediction and clinical utility in familial high-risk studies: Selective review, synthesis, and implications for early detection and intervention

PubMed Central

Shah, Jai L.; Tandon, Neeraj; Keshavan, Matcheri S.

2016-01-01

Aim Accurate prediction of which individuals will go on to develop psychosis would assist early intervention and prevention paradigms. We sought to review investigations of prospective psychosis prediction based on markers and variables examined in longitudinal familial high-risk (FHR) studies. Methods We performed literature searches in MedLine, PubMed and PsycINFO for articles assessing performance characteristics of predictive clinical tests in FHR studies of psychosis. Studies were included if they reported one or more predictive variables in subjects at FHR for psychosis. We complemented this search strategy with references drawn from articles, reviews, book chapters and monographs. Results Across generations of familial high-risk projects, predictive studies have investigated behavioral, cognitive, psychometric, clinical, neuroimaging, and other markers. Recent analyses have incorporated multivariate and multi-domain approaches to risk ascertainment, although with still generally modest results. Conclusions While a broad range of risk factors has been identified, no individual marker or combination of markers can at this time enable accurate prospective prediction of emerging psychosis for individuals at FHR. We outline the complex and multi-level nature of psychotic illness, the myriad of factors influencing its development, and methodological hurdles to accurate and reliable prediction. Prospects and challenges for future generations of FHR studies are discussed in the context of early detection and intervention strategies. PMID:23693118

Which medical device and/or which local treatment for prevention in patients with risk factors for pressure sores in 2012? Developing French guidelines for clinical practice.

PubMed

Nicolas, B; Moiziard, A S; Barrois, B; Colin, D; Michel, J M; Passadori, Y; Ribinik, P

2012-10-01

Implementation of a prevention strategy after the identification of risk factors is essential at the entrance in a care unit or in a medical-social unit. Determine which medical devices and which treatments may be used in order to prevent pressure sore in 2012. Systematic review of the literature using databases: Pascal, Biomed, PubMed, and Cochrane library between 2000 and 2010. Nursing care including use of soft product, non-irritating for the cleaning, hydration of the skin with emollients, protection of fragile skin in case of incontinence by applying a skin protector and application of dressings in front of bony prominences to reduce shear forces, remain valid (level C). Nursing cares and use of dressing in patients with high risks of pressure sores are the responsibility of the nurses. The engagement of health care teams involves screening of risk factors and the knowledge of treatments and local devices. Local preventive treatment in a patient with risk factors of pressure sore is of great interest at entrance in a care unit or in a medical-social unit. Copyright © 2012. Published by Elsevier Masson SAS.

High-risk behaviour in hypomanic states.

PubMed

Fletcher, Kathryn; Parker, Gordon; Paterson, Amelia; Synnott, Howe

2013-08-15

Risk-taking behaviours during hypomanic states are recognised, however the high-risk nature of some behaviours-including the potential for harm to both the individual and others-has not been detailed in the research literature. The current study examines risk-taking behaviours and their consequences (including their potential for impairment) in those with a bipolar II condition. Participants were recruited from the Sydney-based Black Dog Institute Depression Clinic. Diagnostic assignment of bipolar II disorder was based on clinician judgement and formal DSM-IV criteria. Participants completed a series of detailed questions assessing previous risk-taking behaviours during hypomanic states. The sample comprised a total of 93 participants. Risk-taking behaviours during hypomania included spending significant amounts of money, excessive alcohol or drug use, dangerous driving and endangering sexual activities. Key consequences included interpersonal conflict, substantial financial burden and feelings of guilt, shame and remorse. Despite recognition of the risks and consequences associated with hypomanic behaviours, less than one-fifth of participants agreed that hypomania should be treated because of the associated risks. Study limitations included a cross-sectional design, reliance on self-report information, lack of controlling for current mood state, and comprised a tertiary referral sample that may be weighted to more severe cases. Findings may therefore not be generalisable and require replication. Risk-taking behaviours during hypomania are common, and often linked with serious consequences. Whilst hypomania is often enjoyed and romanticised by patients-leading to ambivalence around treatment of such states-careful consideration of the impact of risk-taking behaviour is necessary, while the study raises the question as to what is 'impairment' in hypomania. Findings should advance clinical management by identifying those high-risk behaviours that would benefit from

IMPACT OF STAGE MIGRATION AND PRACTICE CHANGES ON HIGH RISK PROSTATE CANCER: RESULTS FROM PATIENTS TREATED WITH RADICAL PROSTATECTOMY OVER THE LAST TWO DECADES

PubMed Central

Fossati, N.; Passoni, N. M.; Moschini, M.; Gandaglia, G.; Larcher, A.; Freschi, M.; Guazzoni, G.; Sjoberg, D. D.; Vickers, A. J.; Montorsi, F.; Briganti, A.

2016-01-01

Background Phenotype of prostate cancer at diagnosis has changed through the years. We aim to evaluate the impact of year of surgery on clinical, pathologic and oncologic outcomes of high-risk prostate cancer patients. Patients and methods We evaluated 1,033 clinically high-risk patients, defined as the presence of at least one of the following risk factors: pre-operative prostate specific antigen (PSA) level >20 ng/ml, and/or clinical stage ≥T3, and/or biopsy Gleason score ≥8. Patients were treated between 1990 and 2013 at a single Institution. Year-per-year trends of clinical and pathologic characteristics were examined. Multivariable Cox regression analysis was used to test the relationship between year of surgery and oncologic outcomes. Results We observed a decrease over time in the proportion of high-risk patients with a pre-operative PSA level >20 ng/ml or clinical stage cT3. An opposite trend was seen for biopsy Gleason score ≥8. We observed a considerable increase in the median number of lymph nodes removed that was associated with an increased rate of LNI. At multivariable Cox regression analysis, year of surgery was associated with a reduced risk of biochemical recurrence (HR per 5-year: 0.90; 95% CI: 0.84–0.96; p=0.01) and distant metastasis (HR per 5-year: 0.91; 95% CI: 0.83–0.99; p=0.039), after adjusting for age, pre-operative PSA, pathologic stage, lymph node invasion, surgical margin status, and pathological Gleason score. Conclusions In this single center study, an increased diagnosis of localized and less extensive high-grade prostate cancer was observed over the last two decades. High-risk patients selected for radical prostatectomy showed better cancer control over time. Better definitions of what constitutes high-risk prostate cancer among contemporary patients are needed. PMID:25787671

Risk Factors and Predictive Clinical Scores for Asthma Exacerbations in Childhood

PubMed Central

Forno, Erick; Fuhlbrigge, Anne; Soto-Quirós, Manuel E.; Avila, Lydiana; Raby, Benjamin A.; Brehm, John; Sylvia, Jody M.; Weiss, Scott T.

2010-01-01

Background: Asthma is a major public health problem that affects millions of children worldwide, and exacerbations account for most of its morbidity and costs. Primary-care providers lack efficient tools to identify children at high risk for exacerbations. We aimed to construct a clinical score to help providers to identify such children. Methods: Our main outcome was severe asthma exacerbation, which was defined as any hospitalization, urgent visit, or systemic steroid course for asthma in the previous year, in children. A clinical score, consisting of a checklist questionnaire made up of 17 yes-no questions regarding asthma symptoms, use of medications and health-care services, and history, was built and validated in a cross-sectional study of Costa Rican children with asthma. It was then evaluated using data from the Childhood Asthma Management Program (CAMP), a longitudinal trial cohort of North American children. Results: Compared with children at average risk for an exacerbation in the Costa Rican validation set, the odds of an exacerbation among children in the low-risk (OR, 0.2; 95% CI, 0.1-0.4) and high-risk (OR, 5.4; 95% CI, 1.5-19.2) score categories were significantly reduced and increased, respectively. In CAMP, the hazard ratios for an exacerbation after 1-year follow-up in the low-risk and high-risk groups were 0.6 (95% CI, 0.5-0.7) and 1.9 (95% CI, 1.4-2.4), respectively, with similar results at 2 years. Conclusions: The proposed Asthma Exacerbation Clinical Score is simple to use and effective at identifying children at high and low risk for asthma exacerbations. The tool can easily be used in primary-care settings. PMID:20472862

Diagnosis and treatment for clinically localized prostate cancer. Adherence to the European Association of Urology clinical guidelines in a nationwide population-based study - GESCAP group.

PubMed

Gómez-Veiga, F; Rodríguez-Antolín, A; Miñana, B; Hernández, C; Suárez, J F; Fernández-Gómez, J M; Unda, M; Burgos, J; Alcaraz, A; Rodríguez, P; Medina, R; Castiñeiras, J; Moreno, C; Pedrosa, E; Cózar, J M

To assess the adherence to European Association of Urology (EAU) guidelines in the management of prostate cancer (PCa) in Spain. Epidemiological, population-based, study including a national representative sample of 3,918 incident patients with histopathological confirmation during 2010; 95% of the patient's sample was followed up for at least one year. Diagnosis along with treatment related variables (for localized PCa -low, intermediate, high and locally-advanced by D'Amico risk stratification) was recorded. Differences between groups were tested with Chi-squared and Kruskal-Wallis tests. Mean (SD) age of PCa patients was 68.48 (8.18). Regarding diagnostic by biopsy procedures, 64.56% of all patients had 8-12 cores in first biopsy and 46.5% of the patients over 75 years, with PSA<10ng/mL were biopsied. Staging by Computer Tomography (CT) or Bone Scan (BS) was used for determining tumor extension in 60.09% of high-risk cases and was applied differentially depending on patients' age; 3,293 (84.05%) patients received a treatment for localized PCa. Radical prostatectomy was done in 1,277 patients and 206 out of these patients also had a lymphadenectomy, being 4.64% low-risk, 22.81% intermediate-risk and 36.00% high-risk patients; 86.08% of 1,082 patients who had radiotherapy were treated with 3D or IMRT and 35.77% received a dose ≥75Gy; 419 patients were treated with brachytherapy (BT): 54.81% were low-risk patients, 22.84% intermediate-risk and 12.98% high-risk. Hormonotherapy (HT, n=521) was applied as single therapy in 9.46% of low-risk and 17.92% of intermediate-risk patients. Additionally, HT was combined with RT in 14.34% of lower-risk patients and 58.26% of high-risk patients, and 67.19% low-intermediate risk with RT and/or BT received neoadjuvant/concomitant/adjuvant HT. Finally, 83.75% of high-risk patients undergoing RT and/or BT also received HT. Although EAU guidelines for PCa management are easily available in Europe, the adherence to their

Survival outcomes of radical prostatectomy and external beam radiotherapy in clinically localized high-risk prostate cancer: a population-based, propensity score matched study

PubMed Central

Gu, Xiaobin; Gao, Xianshu; Cui, Ming; Xie, Mu; Ma, Mingwei; Qin, Shangbin; Li, Xiaoying; Qi, Xin; Bai, Yun; Wang, Dian

2018-01-01

Objective This study was aimed to compare survival outcomes in high-risk prostate cancer (PCa) patients receiving external beam radiotherapy (EBRT) or radical prostatectomy (RP). Materials and methods The Surveillance, Epidemiology, and End Results (SEER) database was used to identify PCa patients with high-risk features who received RP alone or EBRT alone from 2004 to 2008. Propensity-score matching (PSM) was performed. Kaplan–Meier survival analysis was used to compare cancer-specific survival (CSS) and overall survival (OS). Multivariate Cox regression analysis was used to identify independent prognostic factors. Results A total of 24,293 patients were identified, 14,460 patients receiving RP and 9833 patients receiving EBRT. Through PSM, 3828 patients were identified in each group. The mean CSS was 128.6 and 126.7 months for RP and EBRT groups, respectively (P<0.001). The subgroup analyses showed that CSS of the RP group was better than that of the EBRT group for patients aged <65 years (P<0.001), White race (P<0.001), and married status (P<0.001). However, there was no significant difference in CSS for patients aged ≥65 years, Black race, other race, and unmarried status. Similar trends were observed for OS. Multivariate analysis showed that EBRT treatment modality, T3–T4 stage, Gleason score 8–10, and prostate-specific antigen >20 ng/mL were significant risk factors for both CSS and OS. Conclusion This study suggested that survival outcomes might be better with RP than EBRT in high-risk PCa patients aged <65 years; however, RP and EBRT provided equivalent survival outcomes in older patients, which argues for primary radiotherapy in this older cohort.

Neonatal Candidiasis: Epidemiology, Risk Factors, and Clinical Judgment

PubMed Central

Benjamin, Daniel K.; Stoll, Barbara J.; Gantz, Marie G.; Walsh, Michele C.; Sanchez, Pablo J.; Das, Abhik; Shankaran, Seetha; Higgins, Rosemary D.; Auten, Kathy J.; Miller, Nancy A.; Walsh, Thomas J.; Laptook, Abbot R.; Carlo, Waldemar A.; Kennedy, Kathleen A.; Finer, Neil N.; Duara, Shahnaz; Schibler, Kurt; Chapman, Rachel L.; Van Meurs, Krisa P.; Frantz, Ivan D.; Phelps, Dale L.; Poindexter, Brenda B.; Bell, Edward F.; O’Shea, T. Michael; Watterberg, Kristi L.; Goldberg, Ronald N.

2011-01-01

OBJECTIVE Invasive candidiasis is a leading cause of infection-related morbidity and mortality in extremely low-birth-weight (<1000 g) infants. We quantify risk factors predicting infection in high-risk premature infants and compare clinical judgment with a prediction model of invasive candidiasis. METHODS The study involved a prospective observational cohort of infants <1000 g birth weight at 19 centers of the NICHD Neonatal Research Network. At each sepsis evaluation, clinical information was recorded, cultures obtained, and clinicians prospectively recorded their estimate of the probability of invasive candidiasis. Two models were generated with invasive candidiasis as their outcome: 1) potentially modifiable risk factors and 2) a clinical model at time of blood culture to predict candidiasis. RESULTS Invasive candidiasis occurred in 137/1515 (9.0%) infants and was documented by positive culture from ≥ 1 of these sources: blood (n=96), cerebrospinal fluid (n=9), urine obtained by catheterization (n=52), or other sterile body fluid (n=10). Mortality was not different from infants who had positive blood culture compared to those with isolated positive urine culture. Incidence varied from 2–28% at the 13 centers enrolling ≥ 50 infants. Potentially modifiable risk factors (model 1) included central catheter, broad-spectrum antibiotics (e.g., third-generation cephalosporins), intravenous lipid emulsion, endotracheal tube, and antenatal antibiotics. The clinical prediction model (model 2) had an area under the receiver operating characteristic curve of 0.79, and was superior to clinician judgment (0.70) in predicting subsequent invasive candidiasis. Performance of clinical judgment did not vary significantly with level of training. CONCLUSION Prior antibiotics, presence of a central catheter, endotracheal tube, and center were strongly associated with invasive candidiasis. Modeling was more accurate in predicting invasive candidiasis than clinical judgment. PMID

Assessing the Clinical Role of Genetic Markers of Early-Onset Prostate Cancer Among High-Risk Men Enrolled in Prostate Cancer Early Detection

PubMed Central

Hughes, Lucinda; Zhu, Fang; Ross, Eric; Gross, Laura; Uzzo, Robert G.; Chen, David Y. T.; Viterbo, Rosalia; Rebbeck, Timothy R.; Giri, Veda N.

2011-01-01

Background Men with familial prostate cancer (PCA) and African American men are at risk for developing PCA at younger ages. Genetic markers predicting early-onset PCA may provide clinically useful information to guide screening strategies for high-risk men. We evaluated clinical information from six polymorphisms associated with early-onset PCA in a longitudinal cohort of high-risk men enrolled in PCA early detection with significant African American participation. Methods Eligibility criteria include ages 35–69 with a family history of PCA or African American race. Participants undergo screening and biopsy per study criteria. Six markers associated with early-onset PCA (rs2171492 (7q32), rs6983561 (8q24), rs10993994 (10q11), rs4430796 (17q12), rs1799950 (17q21), and rs266849 (19q13)) were genotyped. Cox models were used to evaluate time to PCA diagnosis and PSA prediction for PCA by genotype. Harrell’s concordance index was used to evaluate predictive accuracy for PCA by PSA and genetic markers. Results 460 participants with complete data and ≥1 follow-up visit were included. 56% were African American. Among African American men, rs6983561 genotype was significantly associated with earlier time to PCA diagnosis (p=0.005) and influenced prediction for PCA by the PSA (p<0.001). When combined with PSA, rs6983561 improved predictive accuracy for PCA compared to PSA alone among African American men (PSA= 0.57 vs. PSA+rs6983561=0.75, p=0.03). Conclusions Early-onset marker rs6983561 adds potentially useful clinical information for African American men undergoing PCA risk assessment. Further study is warranted to validate these findings. Impact Genetic markers of early-onset PCA have potential to refine and personalize PCA early detection for high-risk men. PMID:22144497

Generating local scale land use/cover change scenarios: case studies of high-risk mountain areas

NASA Astrophysics Data System (ADS)

Malek, Žiga; Glade, Thomas; Boerboom, Luc

2014-05-01

The relationship between land use/cover changes and consequences to human well-being is well acknowledged and has led to higher interest of both researchers and decision makers in driving forces and consequences of such changes. For example, removal of natural vegetation cover or urban expansion resulting in new elements at risk can increase hydro-meteorological risk. This is why it is necessary to study how the land use/cover could evolve in the future. Emphasis should especially be given to areas experiencing, or expecting, high rates of socio-economic change. A suitable approach to address these changes is scenario development; it offers exploring possible futures and the corresponding environmental consequences, and aids decision-making, as it enables to analyse possible options. Scenarios provide a creative methodology to depict possible futures, resulting from existing decisions, based on different assumptions of future socio-economic development. They have been used in various disciplines and on various scales, such as flood risk and soil erosion. Several studies have simulated future scenarios of land use/cover changes at a very high success rate, however usually these approaches are tailor made for specific case study areas and fit to available data. This study presents a multi-step scenario generation framework, which can be transferable to other local scale case study areas, taking into account the case study specific consequences of land use/cover changes. Through the use of experts' and decision-makers' knowledge, we aimed to develop a framework with the following characteristics: (1) it enables development of scenarios that are plausible, (2) it can overcome data inaccessibility, (3) it can address intangible and external driving forces of land use/cover change, and (4) it ensures transferability to other local scale case study areas with different land use/cover change processes and consequences. To achieve this, a set of different methods is applied

The utility of the Historical Clinical Risk-20 Scale as a predictor of outcomes in decisions to transfer patients from high to lower levels of security--a UK perspective.

PubMed

Dolan, Mairead; Blattner, Regine

2010-09-29

Structured Professional Judgment (SPJ) approaches to violence risk assessment are increasingly being adopted into clinical practice in international forensic settings. The aim of this study was to examine the predictive validity of the Historical Clinical Risk -20 (HCR-20) violence risk assessment scale for outcome following transfers from high to medium security in a United Kingdom setting. The sample was predominately male and mentally ill and the majority of cases were detained under the criminal section of the Mental Health Act (1986). The HCR-20 was rated based on detailed case file information on 72 cases transferred from high to medium security. Outcomes were examined, independent of risk score, and cases were classed as "success or failure" based on established criteria. The mean length of follow up was 6 years. The total HCR-20 score was a robust predictor of failure at lower levels of security and return to high security. The Clinical and Risk management items contributed most to predictive accuracy. Although the HCR-20 was designed as a violence risk prediction tool our findings suggest it has potential utility in decisions to transfer patients from high to lower levels of security.

Extension of microRNA expression pattern associated with high-risk neuroblastoma.

PubMed

Bienertova-Vasku, Julie; Mazanek, Pavel; Hezova, Renata; Curdova, Anna; Nekvindova, Jana; Kren, Leos; Sterba, Jaroslav; Slaby, Ondrej

2013-08-01

Clinical behavior of neuroblastoma (NBL) is remarkably heterogeneous, as it ranges from spontaneous regression to aggressive clinical phenotype and death. There is increasing body of evidence demonstrating that microRNAs could be considered the potential biomarkers for clinical applications in NBL. In this report, we focus on molecular characterization of high-risk as well as low-risk and intermediate-risk NBL cases in the context of the microRNA expression profile that is specific for the given risk category of the disease. We investigated a total of 30 NBL patients, out of whom there were 19 patients with low- to intermediate-risk and 11 with high-risk NBLs as defined by the Clinical Oncology Group. We determined the expression profiles of 754 microRNAs (miRNAs), whereas the miRNA expression levels were normalized to RNU44, mean expression levels were calculated, and data were analyzed by use of the microarray biostatistical approaches. We identified the signature of 38 miRNAs differentially expressed between these groups of NBL patients (P < 0.05): 17 miRNAs were upregulated and 21 miRNAs were downregulated in the tumors of high-risk NBL patients. We confirm some of the previous observations and we report several new microRNAs associated with aggressive NBL, both being relevant subjects for further translational validation and functional studies.

Clinical dysphagia risk predictors after prolonged orotracheal intubation

PubMed Central

de Medeiros, Gisele Chagas; Sassi, Fernanda Chiarion; Mangilli, Laura Davison; Zilberstein, Bruno; de Andrade, Claudia Regina Furquim

2014-01-01

OBJECTIVES: To elucidate independent risk factors for dysphagia after prolonged orotracheal intubation. METHODS: The participants were 148 consecutive patients who underwent clinical bedside swallowing assessments from September 2009 to September 2011. All patients had received prolonged orotracheal intubations and were admitted to one of several intensive care units of a large Brazilian school hospital. The correlations between the conducted water swallow test results and dysphagia risk levels were analyzed for statistical significance. RESULTS: Of the 148 patients included in the study, 91 were male and 57 were female (mean age, 53.64 years). The univariate analysis results indicated that specific variables, including extraoral loss, multiple swallows, cervical auscultation, vocal quality, cough, choking, and other signs, were possible significant high-risk indicators of dysphagia onset. The multivariate analysis results indicated that cervical auscultation and coughing were independent predictive variables for high dysphagia risk. CONCLUSIONS: Patients displaying extraoral loss, multiple swallows, cervical auscultation, vocal quality, cough, choking and other signs should benefit from early swallowing evaluations. Additionally, early post-extubation dysfunction recognition is paramount in reducing the morbidity rate in this high-risk population. PMID:24473554

Understanding Interrater Reliability and Validity of Risk Assessment Tools Used to Predict Adverse Clinical Events.

PubMed

Siedlecki, Sandra L; Albert, Nancy M

This article will describe how to assess interrater reliability and validity of risk assessment tools, using easy-to-follow formulas, and to provide calculations that demonstrate principles discussed. Clinical nurse specialists should be able to identify risk assessment tools that provide high-quality interrater reliability and the highest validity for predicting true events of importance to clinical settings. Making best practice recommendations for assessment tool use is critical to high-quality patient care and safe practices that impact patient outcomes and nursing resources. Optimal risk assessment tool selection requires knowledge about interrater reliability and tool validity. The clinical nurse specialist will understand the reliability and validity issues associated with risk assessment tools, and be able to evaluate tools using basic calculations. Risk assessment tools are developed to objectively predict quality and safety events and ultimately reduce the risk of event occurrence through preventive interventions. To ensure high-quality tool use, clinical nurse specialists must critically assess tool properties. The better the tool's ability to predict adverse events, the more likely that event risk is mediated. Interrater reliability and validity assessment is relatively an easy skill to master and will result in better decisions when selecting or making recommendations for risk assessment tool use.

Clinical outcomes of whole pelvis radiotherapy and stereotactic body radiotherapy boost for intermediate- and high-risk prostate cancer.

PubMed

Kim, Hun Jung; Phak, Jeong Hoon; Kim, Woo Chul

2017-10-01

We report our experience with Cyberknife to deliver hypofractionated stereotactic body radiotherapy (SBRT) boost combined with whole pelvis radiotherapy (WPRT) to patients with intermediate- to high-risk prostate cancer. From March 2008 to July 2014, 39 patients with newly diagnosed, intermediate- and high-risk (National Comprehensive Cancer Network definition) localized prostate cancer were treated with WPRT and SBRT boost. The whole pelvis dose was 45 Gy (25 fractions of 1.8 Gy) and the SBRT boost dose was 21 Gy (3 fractions of 7 Gy). No one received androgen deprivation therapy before biochemical relapse. The acute and late toxicities were recorded using the Radiation Therapy Oncology Group scale. Prostate-specific antigen (PSA) response was monitored. Thirty-nine patients with a median 53.6 months (range 14-74 months) follow-up were analyzed. The median pretreatment PSA was 15.97 ng/mL. The estimated 5-year biochemical failure (BCF)-free survival was 94.7%. Two BCFs were observed in only high-risk group. The median PSA nadir was 0.30 ng/mL at median 36 months and PSA bounce occurred in 15.4% (n = 6) of patients at median 12 months. No grade 3 acute toxicity was noted. A total of 23% of the patients had grade 2 acute genitourinary (GU) toxicities and 21% had grade 2 acute gastrointestinal (GI) toxicities. At 2 months, most complications had returned to baseline. GU and GI toxicities were observed. WPRT followed by SBRT boost using Cyberknife in intermediate- and high-risk prostate cancer is feasible with minimal toxicity and encouraging BCF-free survival. © 2016 John Wiley & Sons Australia, Ltd.

Preliminary psychometric properties of the brief Negative Symptom Scale in youth at Clinical High-Risk for psychosis.

PubMed

Strauss, Gregory P; Chapman, Hannah C

2018-03-01

Preliminary psychometric properties of an adapted version of the Brief Negative Symptom Scale (BNSS) are reported in youth at Clinical High-Risk for psychosis (CHR). Participants included 29 CHR youth who met criteria for a prodromal syndrome on the Structured Interview for Prodromal Syndromes (SIPS). The adapted BNSS demonstrated excellent internal consistency, convergent validity, and discriminant validity, suggesting that the BNSS has utility for assessing negative symptoms in a CHR population. Copyright © 2017 Elsevier B.V. All rights reserved.

Single-stage anterior high sacrectomy for locally recurrent rectal cancer.

PubMed

Fawaz, Khaled; Khaled, Fawaz; Smith, Myles J; Moises, Cukier; Smith, Andrew J; Yee, Albert J M

2014-03-01

A review of prospectively collected data on a consecutive series of patients undergoing single-stage anterior high sacrectomy for locally recurrent rectal carcinoma (LRRC). To determine the clinical outcome of patients who underwent anterior high sacrectomy for LRRC. High sacrectomy for oncological resection remains technically challenging. Surgery has the potential to achieve cure in carefully selected patients. Complete (R0) tumor excision in LRRC may require sacrectomy. High sacral resections (S3 and above) typically require a combined anterior/supine and posterior/prone procedure. We investigated our experience performing single-stage anterior high sacrectomy for LRRC. A consecutive series of patients with LRRC without systemic metastases who underwent resection with curative intent requiring high sacrectomy were identified. A review of a prospectively maintained colorectal and spine cancer database data was performed. An oblique dome high sacral osteotomy was performed during a single-stage anterior procedure. Outcome measures included surgical resection margin status, hospital length of stay, postoperative complications, physical functioning status, and overall survival. Nineteen consecutive patients were treated between 2002 and 2011. High sacrectomy was performed at sacral level S1-S2 in 4 patients, S2-S3 in 9 patients, and through S3 in 6 patients. An R0 resection margin was achieved histologically in all 19 cases. There was 1 early (<30 d) postoperative death (1/19, 5%). At median follow-up of 38 months, 13 patients had no evidence of residual disease, 1 was alive with disease, and 4 had died of disease. Morbidities occurred in 15 of the 19 patients (79%). Although high sacrectomy may require a combined anterior and posterior surgical approach, our series demonstrates the feasibility of performing single-stage anterior high sacrectomy in LRRC, with acceptable risks and outcomes compared with the literature. The procedure described by us for LRRC lessens

Treating Patients with High-Risk Smoldering Myeloma

Cancer.gov

In this phase III clinical trial, patients with smoldering myeloma classified as high risk for progression will be randomly assigned to undergo standard observation or six 4-week courses of treatment with the drug lenalidomide.

Effects of Comprehensive, Multiple High-Risk Behaviors Prevention Program on High School Students

ERIC Educational Resources Information Center

Collier, Crystal

2013-01-01

The purpose of this mixed methods study was to examine the effect of a multiple high-risk behaviors prevention program applied comprehensively throughout an entire school-system involving universal, selective, and indicated levels of students at a local private high school during a 4-year period. The prevention program was created based upon the…

Clinical application of the Melbourne risk prediction tool in a high-risk upper abdominal surgical population: an observational cohort study.

PubMed

Parry, S; Denehy, L; Berney, S; Browning, L

2014-03-01

(1) To determine the ability of the Melbourne risk prediction tool to predict a pulmonary complication as defined by the Melbourne Group Scale in a medically defined high-risk upper abdominal surgery population during the postoperative period; (2) to identify the incidence of postoperative pulmonary complications; and (3) to examine the risk factors for postoperative pulmonary complications in this high-risk population. Observational cohort study. Tertiary Australian referral centre. 50 individuals who underwent medically defined high-risk upper abdominal surgery. Presence of postoperative pulmonary complications was screened daily for seven days using the Melbourne Group Scale (Version 2). Postoperative pulmonary risk prediction was calculated according to the Melbourne risk prediction tool. (1) Melbourne risk prediction tool; and (2) the incidence of postoperative pulmonary complications. Sixty-six percent (33/50) underwent hepatobiliary or upper gastrointestinal surgery. Mean (SD) anaesthetic duration was 377.8 (165.5) minutes. The risk prediction tool classified 84% (42/50) as high risk. Overall postoperative pulmonary complication incidence was 42% (21/50). The tool was 91% sensitive and 21% specific with a 50% chance of correct classification. This is the first study to externally validate the Melbourne risk prediction tool in an independent medically defined high-risk population. There was a higher incidence of pulmonary complications postoperatively observed compared to that previously reported. Results demonstrated poor validity of the tool in a population already defined medically as high risk and when applied postoperatively. This observational study has identified several important points to consider in future trials. Copyright © 2013 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Local bladder cancer clusters in southeastern Michigan accounting for risk factors, covariates and residential mobility.

PubMed

Jacquez, Geoffrey M; Shi, Chen; Meliker, Jaymie R

2015-01-01

In case control studies disease risk not explained by the significant risk factors is the unexplained risk. Considering unexplained risk for specific populations, places and times can reveal the signature of unidentified risk factors and risk factors not fully accounted for in the case-control study. This potentially can lead to new hypotheses regarding disease causation. Global, local and focused Q-statistics are applied to data from a population-based case-control study of 11 southeast Michigan counties. Analyses were conducted using both year- and age-based measures of time. The analyses were adjusted for arsenic exposure, education, smoking, family history of bladder cancer, occupational exposure to bladder cancer carcinogens, age, gender, and race. Significant global clustering of cases was not found. Such a finding would indicate large-scale clustering of cases relative to controls through time. However, highly significant local clusters were found in Ingham County near Lansing, in Oakland County, and in the City of Jackson, Michigan. The Jackson City cluster was observed in working-ages and is thus consistent with occupational causes. The Ingham County cluster persists over time, suggesting a broad-based geographically defined exposure. Focused clusters were found for 20 industrial sites engaged in manufacturing activities associated with known or suspected bladder cancer carcinogens. Set-based tests that adjusted for multiple testing were not significant, although local clusters persisted through time and temporal trends in probability of local tests were observed. Q analyses provide a powerful tool for unpacking unexplained disease risk from case-control studies. This is particularly useful when the effect of risk factors varies spatially, through time, or through both space and time. For bladder cancer in Michigan, the next step is to investigate causal hypotheses that may explain the excess bladder cancer risk localized to areas of Oakland and Ingham

Failure mode and effects analysis drastically reduced potential risks in clinical trial conduct.

PubMed

Lee, Howard; Lee, Heechan; Baik, Jungmi; Kim, Hyunjung; Kim, Rachel

2017-01-01

Failure mode and effects analysis (FMEA) is a risk management tool to proactively identify and assess the causes and effects of potential failures in a system, thereby preventing them from happening. The objective of this study was to evaluate effectiveness of FMEA applied to an academic clinical trial center in a tertiary care setting. A multidisciplinary FMEA focus group at the Seoul National University Hospital Clinical Trials Center selected 6 core clinical trial processes, for which potential failure modes were identified and their risk priority number (RPN) was assessed. Remedial action plans for high-risk failure modes (RPN >160) were devised and a follow-up RPN scoring was conducted a year later. A total of 114 failure modes were identified with an RPN score ranging 3-378, which was mainly driven by the severity score. Fourteen failure modes were of high risk, 11 of which were addressed by remedial actions. Rescoring showed a dramatic improvement attributed to reduction in the occurrence and detection scores by >3 and >2 points, respectively. FMEA is a powerful tool to improve quality in clinical trials. The Seoul National University Hospital Clinical Trials Center is expanding its FMEA capability to other core clinical trial processes.

Failure mode and effects analysis drastically reduced potential risks in clinical trial conduct

PubMed Central

Baik, Jungmi; Kim, Hyunjung; Kim, Rachel

2017-01-01

Background Failure mode and effects analysis (FMEA) is a risk management tool to proactively identify and assess the causes and effects of potential failures in a system, thereby preventing them from happening. The objective of this study was to evaluate effectiveness of FMEA applied to an academic clinical trial center in a tertiary care setting. Methods A multidisciplinary FMEA focus group at the Seoul National University Hospital Clinical Trials Center selected 6 core clinical trial processes, for which potential failure modes were identified and their risk priority number (RPN) was assessed. Remedial action plans for high-risk failure modes (RPN >160) were devised and a follow-up RPN scoring was conducted a year later. Results A total of 114 failure modes were identified with an RPN score ranging 3–378, which was mainly driven by the severity score. Fourteen failure modes were of high risk, 11 of which were addressed by remedial actions. Rescoring showed a dramatic improvement attributed to reduction in the occurrence and detection scores by >3 and >2 points, respectively. Conclusions FMEA is a powerful tool to improve quality in clinical trials. The Seoul National University Hospital Clinical Trials Center is expanding its FMEA capability to other core clinical trial processes. PMID:29089745

Data-driven directions for effective footwear provision for the high-risk diabetic foot.

PubMed

Arts, M L J; de Haart, M; Waaijman, R; Dahmen, R; Berendsen, H; Nollet, F; Bus, S A

2015-06-01

Custom-made footwear is used to offload the diabetic foot to prevent plantar foot ulcers. This prospective study evaluates the offloading effects of modifying custom-made footwear and aims to provide data-driven directions for the provision of effectively offloading footwear in clinical practice. Eighty-five people with diabetic neuropathy and a recently healed plantar foot ulcer, who participated in a clinical trial on footwear effectiveness, had their custom-made footwear evaluated with in-shoe plantar pressure measurements at three-monthly intervals. Footwear was modified when peak pressure was ≥ 200 kPa. The effect of single and combined footwear modifications on in-shoe peak pressure at these high-pressure target locations was assessed. All footwear modifications significantly reduced peak pressure at the target locations compared with pre-modification levels (range -6.7% to -24.0%, P < 0.001). The metatarsal heads were most frequently targeted. Repositioning an existing (trans-)metatarsal pad in the shoe insole (-15.9% peak pressure relief), applying local cushioning to the insole (-15.0%) and replacing the insole top cover with Plastazote (-14.2%) were the most effective single modifications. Combining a new Plastazote top cover with a trans-metatarsal bar (-24.0% peak pressure relief) or with local cushioning (-22.0%) were the most effective combined modifications. In people with diabetic neuropathy and a recently healed plantar foot ulcer, significant offloading can be achieved at high-risk foot regions by modifying custom-made footwear. These results provide data-driven directions for the design and evaluation of custom-made footwear for high-risk people with diabetes, and essentially mean that each shoe prescribed should incorporate those design features that effectively offload the foot. © 2015 The Authors. Diabetic Medicine © 2015 Diabetes UK.

18F Fluorocholine Dynamic Time-of-Flight PET/MR Imaging in Patients with Newly Diagnosed Intermediate- to High-Risk Prostate Cancer: Initial Clinical-Pathologic Comparisons.

PubMed

Choi, Joon Young; Yang, Jaewon; Noworolski, Susan M; Behr, Spencer; Chang, Albert J; Simko, Jeffry P; Nguyen, Hao G; Carroll, Peter R; Kurhanewicz, John; Seo, Youngho

2017-02-01

Purpose To investigate the initial clinical value of fluorine 18 ( 18 F) fluorocholine (FCH) dynamic positron emission tomography (PET)/magnetic resonance (MR) imaging by comparing its parameters with clinical-pathologic findings in patients with newly diagnosed intermediate- to high-risk prostate cancer (PCa) who plan to undergo radical prostatectomy. Materials and Methods The institutional review board approved the study protocol, and informed written consent was obtained from all subjects for this HIPAA-compliant study. Twelve men (mean age ± standard deviation, 61.7 years ± 8.4; range, 46-74 years) with untreated intermediate- to high-risk PCa characterized according to Cancer of the Prostate Risk Assessment (CAPRA) underwent preoperative FCH dynamic PET/MR imaging followed by radical prostatectomy between April and November 2015. PET/MR imaging parameters including average and maximum K1 (delivery rate constant) and standardized uptake values (SUVs) and Prostate Imaging Reporting and Data System (PI-RADS) version 2 scores were measured and compared with clinical-pathologic characteristics. For statistical analysis, the Spearman rank correlation and Mann-Whitney U tests were performed. Results Of the PET parameters, maximum SUV of primary tumors showed significant correlations with several clinical-pathologic parameters including serum prostate-specific antigen level (ρ = 0.71, P = .01), pathologic stage (ρ = 0.59, P = .043), and postsurgical CAPRA score (ρ = 0.72, P = .008). The overall PI-RADS score showed significant correlations with pathologic tumor volume (ρ = 0.81, P < .001), percentage of tumor cells with Gleason scores greater than 3 (ρ = 0.59, P = .02), and postsurgical CAPRA score (ρ = 0.58, P = .046). The high-risk postsurgical CAPRA score patient group had a significantly higher maximum SUV than did the intermediate-risk group. Combined PET and MR imaging showed improved sensitivity (88%) for prediction of pathologic extraprostatic

Clinical Relevance of 18F-Sodium Fluoride Positron-Emission Tomography in Noninvasive Identification of High-Risk Plaque in Patients With Coronary Artery Disease.

PubMed

Lee, Joo Myung; Bang, Ji-In; Koo, Bon-Kwon; Hwang, Doyeon; Park, Jonghanne; Zhang, Jinlong; Yaliang, Tong; Suh, Minseok; Paeng, Jin Chul; Shiono, Yasutsugu; Kubo, Takashi; Akasaka, Takashi

2017-11-01

18 F-sodium fluoride ( 18 F-NaF) positron-emission tomography has been introduced as a potential noninvasive imaging tool to identify plaques with high-risk characteristics in patients with coronary artery disease. We sought to evaluate the clinical relevance of 18 F-NaF uptake using optical coherence tomography (OCT), intravascular ultrasound (IVUS), and coronary computed tomography angiography in patients with coronary artery disease. The target population consisted of 51 prospectively enrolled patients (93 stenoses) who underwent 18 F-NaF positron-emission tomography before invasive coronary angiography. 18 F-NaF uptake was compared with IVUS- and OCT-derived plaque characteristics. In the coronary computed tomography angiography subgroup (46 lesions), qualitative lesion characteristics were compared between 18 F-NaF-positive and 18 F-NaF-negative plaques using adverse plaque characteristics. The plaques with 18 F-NaF uptake showed significantly higher plaque burden, more frequent posterior attenuation and positive remodeling in IVUS, and significantly higher maximum lipid arc and more frequent microvessels in OCT (all P <0.05). There were no differences in minimum lumen area and area of calcium between 18 F-NaF-positive and 18 F-NaF-negative lesions. Among 51 lesions with 18 F-NaF-positive uptake, 48 lesions (94.1%) had at least one of high-risk characteristics. The 18 F-NaF tissue-to-background ratio in plaques with high-risk characteristics was significantly higher than in those without (1.09 [95% confidence interval, 0.85-1.34] versus 0.62 [95% confidence interval, 0.42-0.82], P <0.001 for IVUS definition; 0.76 [95% confidence interval, 0.54-0.98] versus 0.42 [95% confidence interval, 0.21-0.62], P =0.014 for OCT definition). Among the 15 lesions that met both IVUS- and OCT-defined criteria for high-risk plaque, 14 (93.3%) showed 18 F-NaF-positive uptake. There was no difference in the prevalence of plaques with any adverse plaque characteristics between 18

Clinical characteristics of high plasma adiponectin and high plasma leptin as risk factors for arterial stiffness and related end-organ damage.

PubMed

Kohara, Katsuhiko; Ochi, Masayuki; Okada, Yoko; Yamashita, Taiji; Ohara, Maya; Kato, Takeaki; Nagai, Tokihisa; Tabara, Yasuharu; Igase, Michiya; Miki, Tetsuro

2014-08-01

The relationship between plasma levels of adiponectin and cardiovascular events is inconclusive. We evaluated the clinical characteristics of people with high plasma adiponectin and high plasma leptin levels. Thousand seven hundred participants recruited from visitors to the Anti-Aging Doc were divided into four groups by combining the bipartiles of plasma adiponectin and leptin levels in men and women separately: AL, high adiponectin and high leptin; Al, high adiponectin and low leptin; al, low adiponectin and low leptin; aL, low adiponectin and high leptin. Body composition, including visceral fat area and thigh muscle cross-sectional area (CSA), brachial-ankle pulse wave velocity (baPWV), periventricular hyperintensity, and urinary albumin excretion, were determined. Twenty percent of the studied population fell within the AL group. This group had a significantly higher visceral fat area than the Al group. Thigh muscle CSA was lowest in the AL group among groups. baPWV, brain white matter lesions, and albuminuria findings in the AL group were significantly higher than those of the Al group. Multiple and logistic regression analyses with confounding parameters further confirmed that plasma adiponectin was not an independent determinant for brain and renal small vessel-related disease. These findings suggest that the plasma level of adiponectin alone is not enough for the risk stratification of cardiovascular disease. Leptin resistance associated with skeletal muscle loss in addition to obesity may need to be addressed to identify high risk people with high plasma adiponectin levels. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Surging Seas Risk Finder: A Tool for Local-Scale Flood Risk Assessments in Coastal Cities

NASA Astrophysics Data System (ADS)

Kulp, S. A.; Strauss, B.

2015-12-01

Local decision makers in coastal cities require accurate, accessible, and thorough assessments of flood exposure risk within their individual municipality, in their efforts to mitigate against damage due to future sea level rise. To fill this need, we have developed Climate Central's Surging Seas Risk Finder, an interactive data toolkit which presents our sea level rise and storm surge analysis for every coastal town, city, county, and state within the USA. Using this tool, policy makers can easily zoom in on their local place of interest to receive a detailed flood risk assessment, which synthesizes a wide range of features including total population, socially vulnerable population, housing, property value, road miles, power plants, schools, hospitals, and many other critical facilities. Risk Finder can also be used to identify specific points of interest in danger of exposure at different flood levels. Additionally, this tool provides localized storm surge probabilities and sea level rise projections at tidal gauges along the coast, so that users can quickly understand the risk of flooding in their area over the coming decades.

Optimizer convergence and local minima errors and their clinical importance

NASA Astrophysics Data System (ADS)

Jeraj, Robert; Wu, Chuan; Mackie, Thomas R.

2003-09-01

Two of the errors common in the inverse treatment planning optimization have been investigated. The first error is the optimizer convergence error, which appears because of non-perfect convergence to the global or local solution, usually caused by a non-zero stopping criterion. The second error is the local minima error, which occurs when the objective function is not convex and/or the feasible solution space is not convex. The magnitude of the errors, their relative importance in comparison to other errors as well as their clinical significance in terms of tumour control probability (TCP) and normal tissue complication probability (NTCP) were investigated. Two inherently different optimizers, a stochastic simulated annealing and deterministic gradient method were compared on a clinical example. It was found that for typical optimization the optimizer convergence errors are rather small, especially compared to other convergence errors, e.g., convergence errors due to inaccuracy of the current dose calculation algorithms. This indicates that stopping criteria could often be relaxed leading into optimization speed-ups. The local minima errors were also found to be relatively small and typically in the range of the dose calculation convergence errors. Even for the cases where significantly higher objective function scores were obtained the local minima errors were not significantly higher. Clinical evaluation of the optimizer convergence error showed good correlation between the convergence of the clinical TCP or NTCP measures and convergence of the physical dose distribution. On the other hand, the local minima errors resulted in significantly different TCP or NTCP values (up to a factor of 2) indicating clinical importance of the local minima produced by physical optimization.

Optimizer convergence and local minima errors and their clinical importance.

PubMed

Jeraj, Robert; Wu, Chuan; Mackie, Thomas R

2003-09-07

Two of the errors common in the inverse treatment planning optimization have been investigated. The first error is the optimizer convergence error, which appears because of non-perfect convergence to the global or local solution, usually caused by a non-zero stopping criterion. The second error is the local minima error, which occurs when the objective function is not convex and/or the feasible solution space is not convex. The magnitude of the errors, their relative importance in comparison to other errors as well as their clinical significance in terms of tumour control probability (TCP) and normal tissue complication probability (NTCP) were investigated. Two inherently different optimizers, a stochastic simulated annealing and deterministic gradient method were compared on a clinical example. It was found that for typical optimization the optimizer convergence errors are rather small, especially compared to other convergence errors, e.g., convergence errors due to inaccuracy of the current dose calculation algorithms. This indicates that stopping criteria could often be relaxed leading into optimization speed-ups. The local minima errors were also found to be relatively small and typically in the range of the dose calculation convergence errors. Even for the cases where significantly higher objective function scores were obtained the local minima errors were not significantly higher. Clinical evaluation of the optimizer convergence error showed good correlation between the convergence of the clinical TCP or NTCP measures and convergence of the physical dose distribution. On the other hand, the local minima errors resulted in significantly different TCP or NTCP values (up to a factor of 2) indicating clinical importance of the local minima produced by physical optimization.

Actuarial assessment of violence risk in hospital-based partner assault clinics.

PubMed

Hilton, N Zoe; Harris, Grant T; Holder, Norah

2008-12-01

Hospital-based partner assault clinics are a relatively recent addition to the community response to partner violence. In this study, 66% of 111 women attending hospital clinics for partner assault were physically injured and 43% reported death threats. Few concurrently used other services (shelters or police) and most relied on female friends and relatives for help. Many participants who currently lived with the perpetrator were contemplating leaving but only a third had made plans to do so. Participants faced an unusually high risk of future assault, according to both victim interview using the ODARA actuarial risk assessment and their own perceptions. Findings imply an important role for partner assault clinics and the feasibility of the victim service sector's using the same actuarial risk assessments as the criminal justice system.

Spatial clustering and local risk of leprosy in São Paulo, Brazil.

PubMed

Ramos, Antônio Carlos Vieira; Yamamura, Mellina; Arroyo, Luiz Henrique; Popolin, Marcela Paschoal; Chiaravalloti Neto, Francisco; Palha, Pedro Fredemir; Uchoa, Severina Alice da Costa; Pieri, Flávia Meneguetti; Pinto, Ione Carvalho; Fiorati, Regina Célia; Queiroz, Ana Angélica Rêgo de; Belchior, Aylana de Souza; Dos Santos, Danielle Talita; Garcia, Maria Concebida da Cunha; Crispim, Juliane de Almeida; Alves, Luana Seles; Berra, Thaís Zamboni; Arcêncio, Ricardo Alexandre

2017-02-01

Although the detection rate is decreasing, the proportion of new cases with WHO grade 2 disability (G2D) is increasing, creating concern among policy makers and the Brazilian government. This study aimed to identify spatial clustering of leprosy and classify high-risk areas in a major leprosy cluster using the SatScan method. Data were obtained including all leprosy cases diagnosed between January 2006 and December 2013. In addition to the clinical variable, information was also gathered regarding the G2D of the patient at diagnosis and after treatment. The Scan Spatial statistic test, developed by Kulldorff e Nagarwalla, was used to identify spatial clustering and to measure the local risk (Relative Risk-RR) of leprosy. Maps considering these risks and their confidence intervals were constructed. A total of 434 cases were identified, including 188 (43.31%) borderline leprosy and 101 (23.28%) lepromatous leprosy cases. There was a predominance of males, with ages ranging from 15 to 59 years, and 51 patients (11.75%) presented G2D. Two significant spatial clusters and three significant spatial-temporal clusters were also observed. The main spatial cluster (p = 0.000) contained 90 census tracts, a population of approximately 58,438 inhabitants, detection rate of 22.6 cases per 100,000 people and RR of approximately 3.41 (95%CI = 2.721-4.267). Regarding the spatial-temporal clusters, two clusters were observed, with RR ranging between 24.35 (95%CI = 11.133-52.984) and 15.24 (95%CI = 10.114-22.919). These findings could contribute to improvements in policies and programming, aiming for the eradication of leprosy in Brazil. The Spatial Scan statistic test was found to be an interesting resource for health managers and healthcare professionals to map the vulnerability of areas in terms of leprosy transmission risk and areas of underreporting.

180. Predictors of Being ‘Most Impacted’ by Psychosis in Self-Identity Among Individuals at Clinical High Risk for Psychosis

PubMed Central

Yang, Lawrence; McFarlane, William; Seidman, Larry J.; Corcoran, Cheryl; Link, Bruce; Bryang, Caitlin; Kline, Emily; Cloutier, Anna; Woodberry, Kristen; Kennedy, Leda

2017-01-01

Abstract Background: While the clinical high risk state for psychosis syndrome (CHR) offers substantial benefits, being identified as CHR may also elicit stigma. Specifically, the comparative impacts upon youths’ self-concept of being “told” by others, versus initial self-identification of being at-risk (i.e., what CHR youth themselves “think”) remains unknown. Methods: Stigma assessments were conducted with 100 CHR individuals in an NIH-funded study at Columbia Medical Center, Harvard Medical Center, and Maine Medical Center from 2011 to present. Individuals were assessed whether they had been “told” by health professionals or school officials outside of the specialized CHR clinic that they were at risk and whether they self-identified or themselves “thought” they were at risk. Logistic regression models were used to assess these 2 variables’ effects upon CHR youth being “most impacted” by a psychotic disorder. Results: When examining each variable singly, being told was associated with a 4.67 increased likelihood of being most impacted by psychosis risk (P < .05). Likewise, thinking one was at risk for psychosis when examined alone was associated with a 3.87 increased likelihood of being most impacted by psychosis-risk (P < .05). When entering both variables as predictors, being told remained associated with a 3.61 greater likelihood of being most impacted by psychosis-risk (P < .05). In this model, thinking one was at risk for psychosis was no longer a significant predictor. These results were consistent even after controlling for sociodemographics, clinical variables, and site differences. Conclusion: When both told and think were considered, only being told that one was CHR remained associated with over a 3-fold greater likelihood of being most impacted by psychosis risk. This highlights the importance of “labeling by others,” including by mental health professionals and school officials who are not part of specialized CHR services

High-risk multiple myeloma: a multifaceted entity, multiple therapeutic challenges.

PubMed

Muchtar, Eli; Magen, Hila; Gertz, Morie A

2017-06-01

The term high-risk multiple myeloma is aimed to identify a heterogeneous group of patients who are more likely to progress and die early of their disease. Therefore, recognition of these patients is crucial. With the increase in the number of treatment options, the outcome for high-risk patients has probably improved, although the true extent of this improvement remains unknown, due to both the heterogeneous components of high-risk disease and its under-representation in clinical trials. In this article, we review the definitions of high-risk disease, emphasizing the fact that no single definition can represent the entire high-risk population. In the second part, we review the treatment options available for the management of high-risk myeloma as well as our general approach for high-risk disease. In light of the poor prognosis associated with high-risk myeloma, even in the current era, new approaches for the management of this subset of patients are needed.

Treatment of Locally Advanced Vaginal Cancer With Radiochemotherapy and Magnetic Resonance Image-Guided Adaptive Brachytherapy: Dose-Volume Parameters and First Clinical Results

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dimopoulos, Johannes C.A.; Schmid, Maximilian P., E-mail: maximilian.schmid@akhwien.at; Fidarova, Elena

2012-04-01

Purpose: To investigate the clinical feasibility of magnetic resonance image-guided adaptive brachytherapy (IGABT) for patients with locally advanced vaginal cancer and to report treatment outcomes. Methods and Materials: Thirteen patients with vaginal cancer were treated with external beam radiotherapy (45-50.4 Gy) plus IGABT with or without chemotherapy. Distribution of International Federation of Gynecology and Obstetrics stages among patients were as follows: 4 patients had Stage II cancer, 5 patients had Stage III cancer, and 4 patients had Stage IV cancer. The concept of IGABT as developed for cervix cancer was transferred and adapted for vaginal cancer, with corresponding treatment planningmore » and reporting. Doses were converted to the equivalent dose in 2 Gy, applying the linear quadratic model ({alpha}/{beta} = 10 Gy for tumor; {alpha}/{beta} = 3 for organs at risk). Endpoints studied were gross tumor volume (GTV), dose-volume parameters for high-risk clinical target volume (HRCTV), and organs at risk, local control (LC), adverse side effects, and survival. Results: The mean GTV ({+-} 1 standard deviation) at diagnosis was 45.3 ({+-}30) cm{sup 3}, and the mean GTV at brachytherapy was 10 ({+-}14) cm{sup 3}. The mean D90 for the HRCTV was 86 ({+-}13) Gy. The mean D2cc for bladder, urethra, rectum, and sigmoid colon were 80 ({+-}20) Gy, 76 ({+-}16) Gy, 70 ({+-}9) Gy, and 60 ({+-}9) Gy, respectively. After a median follow-up of 43 months (range, 19-87 months), one local recurrence and two distant metastases cases were observed. Actuarial LC and overall survival rates at 3 years were 92% and 85%. One patient with Stage IVA and 1 patient with Stage III disease experienced fistulas (one vesicovaginal, one rectovaginal), and 1 patient developed periurethral necrosis. Conclusions: The concept of IGABT, originally developed for treating cervix cancer, appears to be applicable to vaginal cancer treatment with only minor adaptations. Dose-volume parameters for

High prevalence of suicide risk in people living with HIV: who is at higher risk?

PubMed

Passos, Susane Müller Klug; Souza, Luciano Dias de Mattos; Spessato, Bárbara Coiro

2014-01-01

A cross-sectional study was developed to evaluate suicide risk and associated factors in HIV/AIDS patients at a regional reference center for the treatment of HIV/AIDS in southern Brazil. We assessed 211 patients in regard to suicide risk, clinical and sociodemographic characteristics, drug use, depression, and anxiety. Suicide risk was assessed with Mini International Neuropsychiatric Interview, Module C. Multivariate analysis was performed using Poisson regression. Of the total sample, 34.1% were at risk of suicide. In the multivariate analysis, the following variables were independently associated with suicide risk: female gender; age up to 47 years; unemployment; indicative of anxiety; indicative of depression; and abuse or addiction on psychoactive substances. Suicide risk is high in this population. Psychosocial factors should be included in the physical and clinical evaluation, given their strong association with suicide risk.

High-risk regions and outbreak modelling of tularemia in humans.

PubMed

Desvars-Larrive, A; Liu, X; Hjertqvist, M; Sjöstedt, A; Johansson, A; Rydén, P

2017-02-01

Sweden reports large and variable numbers of human tularemia cases, but the high-risk regions are anecdotally defined and factors explaining annual variations are poorly understood. Here, high-risk regions were identified by spatial cluster analysis on disease surveillance data for 1984-2012. Negative binomial regression with five previously validated predictors (including predicted mosquito abundance and predictors based on local weather data) was used to model the annual number of tularemia cases within the high-risk regions. Seven high-risk regions were identified with annual incidences of 3·8-44 cases/100 000 inhabitants, accounting for 56·4% of the tularemia cases but only 9·3% of Sweden's population. For all high-risk regions, most cases occurred between July and September. The regression models explained the annual variation of tularemia cases within most high-risk regions and discriminated between years with and without outbreaks. In conclusion, tularemia in Sweden is concentrated in a few high-risk regions and shows high annual and seasonal variations. We present reproducible methods for identifying tularemia high-risk regions and modelling tularemia cases within these regions. The results may help health authorities to target populations at risk and lay the foundation for developing an early warning system for outbreaks.

Acantholytic squamous cell carcinoma is usually associated with hair follicles, not acantholytic actinic keratosis, and is not "high risk": Diagnosis, management, and clinical outcomes in a series of 115 cases.

PubMed

Ogawa, Toru; Kiuru, Maija; Konia, Thomas H; Fung, Maxwell A

2017-02-01

Acantholytic squamous cell carcinoma (aSCC) is regarded as a high-risk variant of cutaneous squamous cell carcinoma (SCC). Acantholytic actinic keratosis (aAK) has been regarded as a precursor risk factor for aSCC. However, supporting evidence is limited. We sought to document clinical features, histologic features, management, and outcomes in a series of aSCC cases. Definitions of aSCC, aAK, and aSCC arising in association with aAK were applied to a consecutive series of aSCC cases. Clinical characteristics and outcomes were obtained from electronic medical records. Of 115 aSCC cases (103 patients, mean age 71.8 years), actinic keratosis was present in 23% (27/115) but only 7.8% (9/115) exhibited associated aAK. Ten cases (10/115, 9%) fulfilled strict histologic criteria for follicular SCC as previously defined, but 50 of 115 (43%) of our aSCC cases exhibited predominant involvement of follicular epithelium rather than epidermis. Clinical outcome (median follow-up, 36 months) was available in 106 of 115 (92%). One patient experienced regional extension (parotid), and 1 patient experienced a local recurrence (nose). No disease-related metastases or deaths were documented. This was a single-institution retrospective study from the United States. The presence of acantholysis in cutaneous SCC does not specifically confer aggressive behavior, a finding that may inform clinical practice guidelines. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

The metabolic syndrome: validity and utility of clinical definitions for cardiovascular disease and diabetes risk prediction.

PubMed

Cameron, Adrian

2010-02-01

The purpose of clinical definitions of the metabolic syndrome is frequently misunderstood. While the metabolic syndrome as a physiological process describes a clustering of numerous age-related metabolic abnormalities that together increase the risk for cardiovascular disease and type 2 diabetes, clinical definitions include obesity which is thought to be a cause rather than a consequence of metabolic disturbance, and several elements that are routinely measured in clinical practice, including high blood pressure, high blood glucose and dyslipidaemia. Obesity is frequently a central player in the development of the metabolic syndrome and should be considered a key component of clinical definitions. Previous clinical definitions have differed in the priority given to obesity. Perhaps more importantly than its role in a clinical definition, however, is obesity in isolation before the hallmarks of metabolic dysfunction that typify the syndrome have developed. This should be treated seriously as an opportunity to prevent the consequences of the global diabetes epidemic now apparent. Clinical definitions were designed to identify a population at high lifetime CVD and type 2 diabetes risk, but in the absence of several major risk factors for each condition, are not optimal risk prediction devices for either. Despite this, the metabolic syndrome has several properties that make it a useful construct, in conjunction with short-term risk prediction algorithms and sound clinical judgement, for the identification of those at high lifetime risk of CVD and diabetes. A recently published consensus definition provides some much needed clarity about what a clinical definition entails. Even this, however, remains a work in progress until more evidence becomes available, particularly in the area of ethnicity-specific waist cut-points. Copyright 2009 Elsevier Ireland Ltd. All rights reserved.

The clinical trajectory of emerging bipolar disorder among the high-risk offspring of bipolar parents: current understanding and future considerations.

PubMed

Duffy, A; Vandeleur, C; Heffer, N; Preisig, M

2017-11-22

Relatively little is known about the onset of bipolar disorder, yet the early illness course is already associated with significant morbidity and mortality. Therefore, characterizing the bipolar illness trajectory is key to risk prediction and early intervention advancement. In this narrative review, we discuss key findings from prospective longitudinal studies of the high-risk offspring of bipolar parents and related meta-analyses that inform us about the clinical trajectory of emerging bipolar disorder. Challenges such as phenotypic and etiologic heterogeneity and the non-specificity of early symptoms and syndromes are highlighted. Implications of the findings for both research and clinical practice are discussed. Bipolar disorder in young people at familial risk does not typically onset with a hypomanic or manic episode. Rather the first activated episode is often preceded by years of impairing psychopathological states that vary over development and across emerging bipolar subtype. Taking heterogeneity into account and adopting a more comprehensive approach to diagnosis seems necessary to advance earlier identification and our understanding of the onset of bipolar disorder.

Management of high-risk Myeloma: an evidence-based review of treatment strategies.

PubMed

Lehners, Nicola; Hayden, Patrick J; Goldschmidt, Hartmut; Raab, Marc-Steffen

2016-08-01

Despite the progress made in the treatment of patients with multiple myeloma over recent decades, a significant cohort with high-risk disease as defined by specific clinical and genetic criteria continue to respond poorly to standard treatment. These patients represent a particular challenge to the treating physician and require early identification as well as personalized treatment strategies. In this review, we discuss the prognostic impact of adverse clinical, radiological and genetic factors, evaluate available scoring systems and highlight key aspects of the therapeutic management of high-risk myeloma. MEDLINE and recent scientific meetings' databases were searched for the keywords 'high-risk' and 'multiple myeloma' and relevant studies relating to both diagnostic and therapeutic approaches were identified. Expert commentary: A case is made for intensive induction using combinations of novel agents, early high-dose therapy supported by autologous stem cell transplantation and the widespread use of maintenance therapies. Novel therapeutic options, especially in the field of immunotherapy, are currently explored in clinical trials and have the potential to further improve outcomes for patients with high-risk multiple myeloma.

Reducing chemotherapy use in clinically high-risk, genomically low-risk pN0 and pN1 early breast cancer patients: five-year data from the prospective, randomised phase 3 West German Study Group (WSG) PlanB trial.

PubMed

Nitz, Ulrike; Gluz, Oleg; Christgen, Matthias; Kates, Ronald E; Clemens, Michael; Malter, Wolfram; Nuding, Benno; Aktas, Bahriye; Kuemmel, Sherko; Reimer, Toralf; Stefek, Andrea; Lorenz-Salehi, Fatemeh; Krabisch, Petra; Just, Marianne; Augustin, Doris; Liedtke, Cornelia; Chao, Calvin; Shak, Steven; Wuerstlein, Rachel; Kreipe, Hans H; Harbeck, Nadia

2017-10-01

The prospective phase 3 PlanB trial used the Oncotype DX ® Recurrence Score ® (RS) to define a genomically low-risk subset of clinically high-risk pN0-1 early breast cancer (EBC) patients for treatment with adjuvant endocrine therapy (ET) alone. Here, we report five-year data evaluating the prognostic value of RS, Ki-67, and other traditional clinicopathological parameters. A central tumour bank was prospectively established within PlanB. Following an early amendment, hormone receptor (HR)+ , pN0-1 RS ≤ 11 patients were recommended to omit chemotherapy. Patients with RS ≥ 12, pN2-3, or HR-negative/HER2-negative disease were randomised to anthracycline-containing or anthracycline-free chemotherapy. Primary endpoint: disease-free survival (DFS). PlanB Clinicaltrials.gov identifier: NCT01049425. From 2009 to 2011, PlanB enrolled 3198 patients (central tumour bank, n = 3073) with the median age of 56 years, 41.1% pN+, and 32.5% grade 3 EBC. Chemotherapy was omitted in 348/404 (86.1%) eligible RS ≤ 11 patients. After 55 months of median follow-up, five-year DFS in ET-treated RS ≤ 11 patients was 94% (in both pN0 and pN1) versus 94% (RS 12-25) and 84% (RS > 25) in chemotherapy-treated patients (p < 0.001); five-year overall survival (OS) was 99 versus 97% and 93%, respectively (p < 0.001). Nodal status, central/local grade, tumour size, continuous Ki-67, progesterone receptor (PR), IHC4, and RS were univariate prognostic factors for DFS. In a multivariate analysis including all univariate prognostic markers, only pN2-3, central and local grade 3, tumour size >2 cm, and RS, but not IHC4 or Ki-67 were independent adverse factors. If RS was excluded, IHC4 or both Ki-67 and PR entered the model. The impact of RS was particularly pronounced in patients with intermediate Ki-67 (>10%, <40%) tumours. The excellent five-year outcomes in clinically high-risk, genomically low-risk (RS ≤ 11) pN0-1 patients without adjuvant chemotherapy support using

[Clinical risk management in german hospitals - does size really matter?].

PubMed

Bohnet-Joschko, S; Jandeck, L M; Zippel, C; Andersen, M; Krummenauer, F

2011-06-01

In the last years, German hospitals have implemented different measures to increase patient safety. Special importance has been attached to near miss reporting systems (critical incident reporting system, CIRS) as instruments for risk identification in health care, instruments that promise high potential for organisational learning. To gain insight into the current status of critical incident reporting systems and other instruments for clinical risk management, a survey among 341 hospitals was carried out in 2009. Questions covered a process of six steps: from risk strategy to methods for risk identification, to risk analysis and risk assessment, to risk controlling and risk monitoring. Structured telephone interviews were conducted with 341 German hospitals, featuring in their statutory quality reports certain predefined key terms that indicated the concluded or planned implementation of clinical risk management. The main objective of those interviews was to check the relation between status/organisation of self-reported risk management and both operator (private, public, NPO) and size of hospital. The implementation of near miss reporting systems (CIRS) in German hospitals has been constantly rising since 2004: in 2009, 54 % of the interviewed hospitals reported an implemented CIRS; of these, 72 % reported the system to be hospital-wide. An association between CIRS and private, public or NPO-operator could not be detected (Fisher p = 1.000); however, the degree of CIRS implementation was significantly increasing with the size of the hospital, i.e., the number of beds (Fisher p = 0.008): only 38 % of the hospitals with less than 100 beds reported CIRS implementation against 52 % of those between 100 to 500 beds, and 67 % of those with more than 500 beds. While 62 % of the hospitals interviewed reported the maintenance of a risk management committee, only 14 % reported the implementation of risk analysing techniques. As to clinical risk

Implementation of evidence-based falls prevention in clinical services for high-risk clients.

PubMed

Day, Lesley; Trotter, Margaret J; Hill, Keith D; Haines, Terry P; Thompson, Catherine

2014-06-01

The extent to which best practice for falls prevention is being routinely delivered by health care providers for community-dwelling older adults is unclear. We investigated falls prevention practice among Hospital Admission Risk Programs (HARP) that provide and coordinate specialized health care for people at high risk of hospitalization. Cross-sectional survey of all HARP services in Victoria, excluding one paediatric programme (n = 34). The questionnaire focused upon medication review and exercise prescription, as these are the evidence-based falls interventions with a good fit with HARP services. Completed questionnaires were received from 24 programmes (70.6%) that service 15,250 older clients (60+ years). All except one programme screened for medicine use; however, a lower proportion (65% of those that screen) target falls risk medications. Among the 17 programmes responding to the exercise prescription question, all routinely include strengthening exercises, and almost all (n = 15) include flexibility, endurance training and movement of the centre of gravity. A lesser proportion (71%) includes reducing the need for upper limb support. The majority of services (88%) undertake falls risk assessments, and all of these either make referral appointments for clients or refer to other services that make referral appointments for clients. Follow-up of appointments and the resulting recommendations was high. Screening for falls risk medications could be improved and staff training in exercise prescription for balance challenge in this high-risk group may be needed. Although evidence-based falls prevention practice within Victorian HARP services appears strong, the effect on falls risk may not be as high as that achieved in randomized trials. © 2014 John Wiley & Sons, Ltd.

Psychosocial Adaptation and Depressive Manifestations in High-Risk Pregnant Women: Implications for Clinical Practice.

PubMed

Fiskin, Gamze; Kaydirak, Meltem Mecdi; Oskay, Umran Yesiltepe

2017-02-01

High-risk pregnancy research has focused primarily on psychological well-being. The aim is to determine psychosocial adaptation and depression levels of pregnant women who were admitted to hospital with diagnosis of high-risk pregnancy. This study was descriptive. Sampling was composed of 122 high-risk pregnant women who were hospitalized in the perinatology service of Istanbul University Medical School, Department of Obstetrics and Gynecology between January 1, 2014, and May 31, 2014, and met the study criteria. The Pregnant Introduction Form, Psychosocial Adjustment of Illness Scale-Self Report, and CES Depression Scale were used. Of high-risk pregnant women, 47% were found to have a poor level of psychosocial adaptation and 57% presented with depressive symptoms. There were statistically significant difference found between the levels of psychosocial adaptation and status of depressive manifestations. The difference between the average scores increased as the adaptation levels weaken and the pregnant women with a poor level of psychosocial adaptation showed more depressive manifestations. The results of this study indicate that, depending on the high-risk pregnancy status, pregnant women experience difficulty in adaptation to their current status and pregnant women with a poor level of psychosocial adaptation showed more depressive manifestations. Nurses should deliver care in high-risk pregnancies with the awareness of physiological needs as well the psychosocial needs of pregnant women, and information meetings should be held in order to increase the psychosocial support of their families and decrease their tendency toward depression. Nursing initiatives should be developed with further studies for the psychosocial adaptation of high-risk pregnancy and reduction of the depressive manifestations. © 2016 Sigma Theta Tau International.

Three-month posttreatment prostate-specific antigen level as a biomarker of treatment response in patients with intermediate-risk or high-risk prostate cancer treated with androgen deprivation therapy and radiotherapy.

PubMed

Bryant, Alex K; D'Amico, Anthony V; Nguyen, Paul L; Einck, John P; Kane, Christopher J; McKay, Rana R; Simpson, Daniel R; Mundt, Arno J; Murphy, James D; Rose, Brent S

2018-05-04

Prostate-specific antigen (PSA) measurement after definitive radiotherapy (RT) and androgen deprivation therapy for localized prostate cancer has been proposed as an early prognostic biomarker. In the current study, the authors investigated the association between 3-month post-RT PSA level and biochemical progression-free survival (bPFS), prostate cancer-specific survival (PCSS), and overall survival (OS). A total of 5783 patients with intermediate-risk or high-risk localized prostate cancer who were diagnosed between 2000 and 2015 and treated with RT and androgen deprivation therapy were identified from Veterans Affairs data. Patients were divided into groups based on 3-month post-RT PSA values: <0.10 ng/mL, 0.10 to 0.49 ng/mL, and ≥0.50 ng/mL. The effect of the 3-month PSA group on bPFS, PCSS, and OS was evaluated in multivariable Cox models adjusting for potential confounders. There were 2651 patients with intermediate-risk and 3132 with high-risk disease; approximately 11% had a 3-month PSA level of ≥0.50 ng/mL. A higher 3-month PSA level was found to be strongly associated with each outcome; compared with patients in the group with a 3-month PSA value <0.10 ng/mL, the authors noted greater hazards for the patients with a 3-month PSA value ≥0.50 ng/mL (hazard ratio for bPFS: 5.23; PCSS: 3.97; and OS: 1.50 [P<.001 for all]) and the patients with a 3-month PSA value of 0.10 to 0.49 ng/mL (hazard ratio for bPFS: 2.41 [P<.001]; PCSS: 2.29 [P<.001]; and OS: 1.21 [P = .003]). When analyzed separately, the 3-month PSA level was found to be predictive of OS in the high-risk group (P<.001) but not the intermediate-risk group (P = .21). The 3-month post-RT PSA level appears to be a strong prognostic biomarker for bPFS, PCSS, and OS in patients with intermediate-risk and high-risk prostate cancer, particularly those with high-risk disease. The 3-month PSA measurement may augment clinical decision making and holds promise as a potential

The German clinical risk management survey for hospitals: Implementation levels and areas for improvement in 2015.

PubMed

Manser, Tanja; Frings, Janina; Heuser, Gregory; Mc Dermott, Fiona

2016-01-01

Despite the growing recognition of the need to implement systematic approaches for managing the risks associated with healthcare, few studies have investigated the level of implementation for clinical risk management (CRM) at a national level. Therefore, this study aimed to assess the current level of CRM implementation in German hospitals and to explore differences across hospital types. From March to June 2015, persons responsible for CRM in 2,617 hospitals and rehabilitation clinics in Germany were invited to participate in a voluntary online survey assessing the level of implementation for various aspects of CRM: CRM strategy, structures and processes; risk assessment (risk identification, risk analysis, risk evaluation) with a focus on incident reporting systems; risk mitigation measures; and risk monitoring and reporting. 572 hospitals participated in the survey (response rate 22 %). Most of these hospitals had a formalised, binding CRM strategy (72 %). 66 % had a centralised and 34 % a decentralised CRM structure. We also found that, despite a broad range of risk assessment methods being applied, there was a lack of integration of risk information from different data sources. Hospitals also reported a high level of implementation of critical incident reporting systems with a strong preference for local (74 %) over transorganisational systems. This study provides relevant data to inform targeted interventions concerning CRM implementation at a national level and to consider the specific context of different types of hospitals more carefully in this process. The approach to CRM assessment illustrated in this article could be the basis of a system for monitoring CRM over time and, thus, for evaluating the impact of strategy decisions at the policy level on CRM development. Copyright © 2016. Published by Elsevier GmbH.

Intraperitoneal local anaesthetic instillation versus no intraperitoneal local anaesthetic instillation for laparoscopic cholecystectomy.

PubMed

Gurusamy, Kurinchi Selvan; Nagendran, Myura; Guerrini, Gian Piero; Toon, Clare D; Zinnuroglu, Murat; Davidson, Brian R

2014-03-13

While laparoscopic cholecystectomy is generally considered less painful than open surgery, pain is one of the important reasons for delayed discharge after day surgery and overnight stay laparoscopic cholecystectomy. The safety and effectiveness of intraperitoneal local anaesthetic instillation in people undergoing laparoscopic cholecystectomy is unknown. To assess the benefits and harms of intraperitoneal instillation of local anaesthetic agents in people undergoing laparoscopic cholecystectomy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and Science Citation Index Expanded to March 2013 to identify randomised clinical trials of relevance to this review. We considered only randomised clinical trials (irrespective of language, blinding, or publication status) comparing local anaesthetic intraperitoneal instillation versus placebo, no intervention, or inactive control during laparoscopic cholecystectomy for the review with regards to benefits while we considered quasi-randomised studies and non-randomised studies for treatment-related harms. Two review authors collected the data independently. We analysed the data with both fixed-effect and random-effects models using Review Manager 5 analysis. For each outcome, we calculated the risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI). We included 58 trials, of which 48 trials with 2849 participants randomised to intraperitoneal local anaesthetic instillation (1558 participants) versus control (1291 participants) contributed data to one or more of the outcomes. All the trials except one trial with 30 participants were at high risk of bias. Most trials included only low anaesthetic risk people undergoing elective laparoscopic cholecystectomy. Various intraperitoneal local anaesthetic agents were used but bupivacaine in the liquid form was the most common local anaesthetic used. There were considerable differences in the methods of local anaesthetic

A probabilistic topic model for clinical risk stratification from electronic health records.

PubMed

Huang, Zhengxing; Dong, Wei; Duan, Huilong

2015-12-01

Risk stratification aims to provide physicians with the accurate assessment of a patient's clinical risk such that an individualized prevention or management strategy can be developed and delivered. Existing risk stratification techniques mainly focus on predicting the overall risk of an individual patient in a supervised manner, and, at the cohort level, often offer little insight beyond a flat score-based segmentation from the labeled clinical dataset. To this end, in this paper, we propose a new approach for risk stratification by exploring a large volume of electronic health records (EHRs) in an unsupervised fashion. Along this line, this paper proposes a novel probabilistic topic modeling framework called probabilistic risk stratification model (PRSM) based on Latent Dirichlet Allocation (LDA). The proposed PRSM recognizes a patient clinical state as a probabilistic combination of latent sub-profiles, and generates sub-profile-specific risk tiers of patients from their EHRs in a fully unsupervised fashion. The achieved stratification results can be easily recognized as high-, medium- and low-risk, respectively. In addition, we present an extension of PRSM, called weakly supervised PRSM (WS-PRSM) by incorporating minimum prior information into the model, in order to improve the risk stratification accuracy, and to make our models highly portable to risk stratification tasks of various diseases. We verify the effectiveness of the proposed approach on a clinical dataset containing 3463 coronary heart disease (CHD) patient instances. Both PRSM and WS-PRSM were compared with two established supervised risk stratification algorithms, i.e., logistic regression and support vector machine, and showed the effectiveness of our models in risk stratification of CHD in terms of the Area Under the receiver operating characteristic Curve (AUC) analysis. As well, in comparison with PRSM, WS-PRSM has over 2% performance gain, on the experimental dataset, demonstrating that

Systemic Therapy for Youth at Clinical High Risk for Psychosis: A Pilot Study.

PubMed

Shi, Jingyu; Wang, Lu; Yao, Yuhong; Zhan, Chenyu; Su, Na; Zhao, Xudong

2017-01-01

Psychosocial intervention trials for youth at clinical high risk (CHR) for psychosis have shown promising effects on treating psychotic symptoms but have not focused on psychosocial functional outcomes, and those studies have been conducted among help-seeking patients; there is a lack of research on non-clinical young CHR individuals. Systemic therapy (ST) is grounded in systemic-constructivist and psychosocial resilience theories. It has a number of advantages that makes it attractive for use with CHR individuals in non-clinical context. The present study evaluated the effect of ST for students at CHR on reducing symptoms and enhancing psychosocial function. This was a single-blind randomized controlled trial for CHR young people comparing ST to supportive therapy with a 6-month treatment. Psychotic and depressive symptoms (DS) as well as self-esteem and social support (SS) were assessed at pre- and posttreatment. 26 CHR individuals were randomly divided into intervention group ( n  = 13) and control group ( n  = 13). There were no significant differences in severity of symptoms, level of SS and self-esteem at baseline between the two groups ( P  > 0.05). At posttreatment, significant improvements in positive and DS as well as SS and self-esteem were observed in the ST group ( P  < 0.05); in the control group, these improvements were not significant ( P  > 0.05). The findings indicated that systemic intervention for university students at CHR for psychosis may have a positive effect on symptoms and self-esteem as well as SS in short term. More long-term research is needed to further evaluate this intervention.

Stronger default mode network connectivity is associated with poorer clinical insight in youth at ultra high-risk for psychotic disorders.

PubMed

Clark, Sarah V; Mittal, Vijay A; Bernard, Jessica A; Ahmadi, Aral; King, Tricia Z; Turner, Jessica A

2018-03-01

Impaired clinical insight (CI) is a common symptom of psychotic disorders and a promising treatment target. However, to date, our understanding of how variability in CI is tied to underlying brain dysfunction in the clinical high-risk period is limited. Developing a stronger conception of this link will be a vital first step for efforts to determine if CI can serve as a useful prognostic indicator. The current study investigated whether variability in CI is related to major brain networks in adolescents and young adults at ultra high-risk (UHR) of developing psychosis. Thirty-five UHR youth were administered structured clinical interviews as well as an assessment for CI and underwent resting-state magnetic resonance imaging scans. Functional connectivity was calculated in the default mode network (DMN) and fronto-parietal network (FPN), two major networks that are dysfunctional in psychosis and are hypothesized to affect insight. Greater DMN connectivity between the posterior cingulate/precuneus and ventromedial prefrontal cortex (DMN) was related to poorer CI (R 2 =0.399). There were no significant relationships between insight and the FPN. This is the first study to relate a major brain network to clinical insight before the onset of psychosis. Findings are consistent with evidence if a hyperconnected DMN in schizophrenia and UHR, and similar to a previous study of insight and connectivity in schizophrenia. Results suggest that a strongly connected DMN may be related to poor self-awareness of subthreshold psychotic symptoms in UHR adolescents and young adults. Copyright © 2017 Elsevier B.V. All rights reserved.

Risk determination after an acute myocardial infarction: review of 3 clinical risk prediction tools.

PubMed

Scruth, Elizabeth Ann; Page, Karen; Cheng, Eugene; Campbell, Michelle; Worrall-Carter, Linda

2012-01-01

The objective of the study was to provide comprehensive information for the clinical nurse specialist (CNS) on commonly used clinical prediction (risk assessment) tools used to estimate risk of a secondary cardiac or noncardiac event and mortality in patients undergoing primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI). The evolution and widespread adoption of primary PCI represent major advances in the treatment of acute myocardial infarction, specifically STEMI. The American College of Cardiology and the American Heart Association have recommended early risk stratification for patients presenting with acute coronary syndromes using several clinical risk scores to identify patients' mortality and secondary event risk after PCI. Clinical nurse specialists are integral to any performance improvement strategy. Their knowledge and understandings of clinical prediction tools will be essential in carrying out important assessment, identifying and managing risk in patients who have sustained a STEMI, and enhancing discharge education including counseling on medications and lifestyle changes. Over the past 2 decades, risk scores have been developed from clinical trials to facilitate risk assessment. There are several risk scores that can be used to determine in-hospital and short-term survival. This article critiques the most common tools: the Thrombolytic in Myocardial Infarction risk score, the Global Registry of Acute Coronary Events risk score, and the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications risk score. The importance of incorporating risk screening assessment tools (that are important for clinical prediction models) to guide therapeutic management of patients cannot be underestimated. The ability to forecast secondary risk after a STEMI will assist in determining which patients would require the most aggressive level of treatment and monitoring postintervention including

The profile of high-risk pregnancy in El-Mansoura city.

PubMed

Yassin, Shadia A T; Gamal El-Deen, Amany A; Emam, Mohamed A; Omer, Abeer K F

2005-01-01

Proper screening techniques should be used for all pregnant women attending antenatal clinics to pick up the factors that qualify the pregnant women for a risky pregnancy. High-risk pregnancy identification is a challenging work. This study aimed to describe the profile of high-risk pregnancy in El-Mansoura city. The study was conducted on 750 pregnant women attending antenatal clinics in three hospitals in El-Mansoura city, where 250 women were chosen from each setting. A modified version of Morrison and Olsen (1979) high risk scoring inventory tool was used to collect the socioeconomic, biological, medical, reproductive and current pregnancy risk factors in the study sample. It also assessed the risk level whether low, moderate or high. The results revealed that among all women, 63.8% of the sample were at a high-risk, while 25.0 % of them were at a moderate-risk and only 11.2% were at low-risk. About 70.0% of the high-risk pregnant women were in their third trimester followed by 23.0% in the second trimester and only 7.1% were in the first trimester. About 5.9% of the women were at a high-risk because of polluted housing condition, 1.9% because of heart diseases Class capital I, Ukrainian or II, 5.2% because of diabetes mellitus, 4.2% because of hypertension and 14.9% because of previous cesarean section. On the other hand 14.8% women were at moderate risk because of their illiteracy, 29.2% of them for being short, 14.7%, 10.6% of them because of being teenagers or over 35 years of age, respectively, 12.6% of because they had a history of gestational diabetes and 32.8%of them because of anemia, 23.2% because urinary tract infection, 16.9% because of albuminuria, and 12.0% because of glucoseuria. Finally identifying the profile of high -risk pregnancy women is mandatory.

Genetic Risk, Coronary Heart Disease Events, and the Clinical Benefit of Statin Therapy

PubMed Central

Smith, JG; Chasman, DI; Caulfield, M; Devlin, JJ; Nordio, F; Hyde, C; Cannon, CP; Sacks, F; Poulter, N; Sever, P; Ridker, PM; Braunwald, E; Melander, O

2015-01-01

Background Genetic variants have been associated with the risk of coronary heart disease (CHD). We tested whether a composite of these variants could identify the risk of both incident as well as recurrent CHD events and distinguish individuals who derived greater clinical benefit from statin therapy. Methods A community-based cohort and four randomized controlled trials of both primary (JUPITER and ASCOT) and secondary (CARE and PROVE IT-TIMI 22) prevention with statin therapy totaling 48,421 individuals and 3,477 events were included in these analyses. We examined the association of a genetic risk score based on 27 genetic variants with incident or recurrent CHD, adjusting for established clinical predictors. We then investigated the relative and absolute risk reductions in CHD events with statin therapy stratified by genetic risk. Data from studies were combined using meta-analysis. Findings When individuals were divided into low (quintile 1), intermediate (quintiles 2-4), and high (quintile 5) genetic risk categories, a significant gradient of risk for incident or recurrent CHD was demonstrated with the multivariable-adjusted HRs (95% CI) for CHD for the intermediate and high genetic risk categories vs. low genetic risk category being 1.32 (1.20-1.46, P<0.0001) and 1.71 (1.54-1.91, P<0.0001), respectively. In terms of the benefit of statin therapy in the four randomized trials, there was a significant gradient of increasing relative risk reduction across the low, intermediate, and high genetic risk categories (13%, 29%, and 48%, P=0.0277). Similarly, greater absolute risk reductions were seen in those individuals in higher genetic risk categories (P=0.0101), resulting in an approximate three-fold gradient in the number needed to treat (NNT) in the primary prevention trials. Specifically, in the primary prevention trials, the NNT to prevent one MACE over 10 years for the low, intermediate, and high GRS individuals was 66, 42, and 25 in JUPITER and 57, 47, and 20

Update on the Management of High-Risk Penetrating Keratoplasty

PubMed Central

Jabbehdari, Sayena; Rafii, Alireza Baradaran; Yazdanpanah, Ghasem; Hamrah, Pedram; Holland, Edward J.; Djalilian, Ali R

2017-01-01

Purpose of review In this article, we review the indications and latest management of high-risk penetrating keratoplasty. Recent findings Despite the immune-privilege status of the cornea, immune-mediated graft rejection still remains the leading cause of corneal graft failure. This is particularly a problem in the high-risk graft recipients, namely patients with previous graft failure due to rejection and those with inflamed and vascularized corneal beds. A number of strategies including both local and systemic immunosuppression are currently used to increase the success rate of high-risk corneal grafts. Moreover, in cases of limbal stem cell deficiency, limbal stem cells transplantation is employed. Summary Corticosteroids are still the top medication for prevention and treatment in cases of corneal graft rejection. Single and combined administration of immunosuppressive agents e.g. tacrolimus, cyclosporine and mycophenolate are promising adjunctive therapies for prolonging graft survival. In the future, cellular and molecular therapies should allow us to achieve immunologic tolerance even in high-risk grafts. PMID:28959505

Update on the Management of High-Risk Penetrating Keratoplasty.

PubMed

Jabbehdari, Sayena; Rafii, Alireza Baradaran; Yazdanpanah, Ghasem; Hamrah, Pedram; Holland, Edward J; Djalilian, Ali R

2017-03-01

In this article, we review the indications and latest management of high-risk penetrating keratoplasty. Despite the immune-privilege status of the cornea, immune-mediated graft rejection still remains the leading cause of corneal graft failure. This is particularly a problem in the high-risk graft recipients, namely patients with previous graft failure due to rejection and those with inflamed and vascularized corneal beds. A number of strategies including both local and systemic immunosuppression are currently used to increase the success rate of high-risk corneal grafts. Moreover, in cases of limbal stem cell deficiency, limbal stem cells transplantation is employed. Corticosteroids are still the top medication for prevention and treatment in cases of corneal graft rejection. Single and combined administration of immunosuppressive agents e.g. tacrolimus, cyclosporine and mycophenolate are promising adjunctive therapies for prolonging graft survival. In the future, cellular and molecular therapies should allow us to achieve immunologic tolerance even in high-risk grafts.

Risk assessment instruments in clinical practice.

PubMed

Côté, Gilles; Crocker, Anne G; Nicholls, Tonia L; Seto, Michael C

2012-04-01

To determine whether the items in one of the most widely validated instruments of violence risk assessment, the Historical-Clinical-Risk Management-20 (HCR-20), are used in review board hearings to assess the risk of violence by people found Not Criminally Responsible on account of Mental Disorder (NCRMD). This study was conducted from October 2004 to August 2006 in Quebec's sole forensic psychiatric hospital and 2 large civil psychiatric hospitals designated for the care of people declared NCRMD in the Montreal metropolitan area. The risk assessments presented by clinicians at annual review board hearings and the boards' rationale for the release or detention of people found NCRMD were contrasted with the risk assessments conducted by the research team using the HCR-20. The final sample was comprised of 96 men. Very few of the risk factors identified by prior research (HCR-20 items) were mentioned in the hearing process, whether in clinical reports, discussions during the hearing, or in the disposition justification. The findings confirm that there remains a significant gap between research evidence and risk assessment practice.

Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011.

PubMed

Rathi, Vinay K; Krumholz, Harlan M; Masoudi, Frederick A; Ross, Joseph S

2015-08-11

The US Food and Drug Administration (FDA) approves high-risk medical devices, those that support or sustain human life or present potential unreasonable risk to patients, via the Premarket Approval (PMA) pathway. The generation of clinical evidence to understand device safety and effectiveness is shifting from predominantly premarket to continual study throughout the total product life cycle. To characterize the clinical evidence generated for high-risk therapeutic devices over the total product life cycle. All clinical studies of high-risk therapeutic devices receiving initial market approval via the PMA pathway in 2010 and 2011 identified through ClinicalTrials.gov and publicly available FDA documents as of October 2014. Studies were characterized by type (pivotal, studies that served as the basis of FDA approval; FDA-required postapproval studies [PAS]; or manufacturer/investigator-initiated); premarket or postmarket; status (completed, ongoing, or terminated/unknown); and design features, including enrollment, comparator, and longest duration of primary effectiveness end point follow-up. In 2010 and 2011, 28 high-risk therapeutic devices received initial marketing approval via the PMA pathway. We identified 286 clinical studies of these devices: 82 (28.7%) premarket and 204 (71.3%) postmarket, among which there were 52 (18.2%) nonpivotal premarket studies, 30 (10.5%) pivotal premarket studies, 33 (11.5%) FDA-required PAS, and 171 (59.8%) manufacturer/investigator-initiated postmarket studies. Six of 33 (18.2%) PAS and 20 of 171 (11.7%) manufacturer/investigator-initiated postmarket studies were reported as completed. No postmarket studies were identified for 5 (17.9%) devices; 3 or fewer were identified for 13 (46.4%) devices overall. Median enrollment was 65 patients (interquartile range [IQR], 25-111), 241 patients (IQR, 147-415), 222 patients (IQR, 119-640), and 250 patients (IQR, 60-800) for nonpivotal premarket, pivotal, FDA-required PAS, and manufacturer

Mapping Patterns of Ipsilateral Supraclavicular Nodal Metastases in Breast Cancer: Rethinking the Clinical Target Volume for High-risk Patients

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jing, Hao; Wang, Shu-Lian, E-mail: wsl20040118@yahoo.com; Li, Jing

2015-10-01

Purpose: To map the location of metastatic supraclavicular (SCV) lymph nodes (LNMs) in breast cancer patients with SCV node involvement and determine whether and where the radiation therapy clinical target volume (CTV) of this region could be modified in high-risk subsets. Methods and Materials: Fifty-five patients with metastatic SCV LNMs were eligible for geographic mapping and atlas coverage analysis. All LNMs and their epicenters were registered proportionally by referencing the surrounding landmarks onto simulation computed tomography images of a standard patient. CTVs based on selected SCV atlases, including the one by the Radiation Therapy Oncology Group (RTOG) were contoured. Amore » modified SCV CTV was tried and shown to have better involved-node coverage and thus theoretically improved prophylaxis in this setting. Results: A total of 50 (91%) and 45 (81.8%) patients had LNMs in the medial and lateral SCV subregions, respectively. Also, 36 patients (65.5%) had LNMs located at the junction of the jugular-subclavian veins. All nodes were covered in only 25.5% to 41.8% of patients by different atlases. The RTOG atlas covered all nodes in 25.5% of patients. Stratified by the nodes in all the patients as a whole, 49.2% to 81.3% were covered, and the RTOG atlas covered 62.6%. The lateral and posterior borders were the most overlooked locations. Modification by extending the borders to natural anatomic barriers allowed the new CTV to cover all the nodes in 81.8% of patients and encompass 96.1% of all the nodes. Conclusions: According to the distribution of SCV LNMs, the extent of existing atlases might not be adequate for potential metastatic sites in certain groups of patients. The extension of the lateral and posterior CTV borders in high-risk or recurrent patients might be a reasonable approach for increasing coverage. However, additional data in more homogeneous populations with localized disease are needed before routine application.« less

Benefits and risks of using local anaesthetic for pain relief to allow early return to play in professional football

PubMed Central

Orchard, J

2002-01-01

Objective: To investigate the risks and benefits of the use of local anaesthetic in a descriptive case series from three professional football (rugby league and Australian football) teams. Methods: Cases of local anaesthetic use (both injection and topical routes) and complications over a six year period were recorded. Complications were assessed using clinical presentation and also by recording all cases of surgery, incidences of players missing games or leaving the field through injury, and causes of player retirement. Results: There were 268 injuries for which local anaesthetic was used to allow early return to play. There were 11 minor and six major complications, although none of these were catastrophic or career ending. About 10% of players taking the field did so with the assistance of local anaesthetic. This rate should be considered in isolation and not seen to reflect standard practice by team doctors. Conclusions: The use of local anaesthetic in professional football may reduce the rates of players missing matches through injury, but there is the risk of worsening the injury, which should be fully explained to players. A procedure should only be used when both the doctor and player consider that the benefits outweigh the risks. PMID:12055117

Community cardiovascular disease risk from cross-sectional general practice clinical data: a spatial analysis.

PubMed

Bagheri, Nasser; Gilmour, Bridget; McRae, Ian; Konings, Paul; Dawda, Paresh; Del Fante, Peter; van Weel, Chris

2015-02-26

Cardiovascular disease (CVD) continues to be a leading cause of illness and death among adults worldwide. The objective of this study was to calculate a CVD risk score from general practice (GP) clinical records and assess spatial variations of CVD risk in communities. We used GP clinical data for 4,740 men and women aged 30 to 74 years with no history of CVD. A 10-year absolute CVD risk score was calculated based on the Framingham risk equation. The individual risk scores were aggregated within each Statistical Area Level One (SA1) to predict the level of CVD risk in that area. Finally, the pattern of CVD risk was visualized to highlight communities with high and low risk of CVD. The overall 10-year risk of CVD in our sample population was 14.6% (95% confidence interval [CI], 14.3%-14.9%). Of the 4,740 patients in our study, 26.7% were at high risk, 29.8% were at moderate risk, and 43.5% were at low risk for CVD over 10 years. The proportion of patients at high risk for CVD was significantly higher in the communities of low socioeconomic status. This study illustrates methods to further explore prevalence, location, and correlates of CVD to identify communities of high levels of unmet need for cardiovascular care and to enable geographic targeting of effective interventions for enhancing early and timely detection and management of CVD in those communities.

Preparing for Local Adaptation: Understanding Flood Risk Perceptions in Pittsburgh

NASA Astrophysics Data System (ADS)

Klima, K.; Wong-Parodi, G.

2015-12-01

The City of Pittsburgh experiences numerous floods every year. Aging and insufficient infrastructure contribute to flash floods and to over 20 billion gallons of combined sewer overflows annually, contaminating Pittsburgh's streets, basements, and waterways. Climate change is expected to further exacerbate this problem by causing more intense and more frequent extreme precipitation events in Western Pennsylvania. For a stormwater adaptation plan to be implemented effectively, the City will need informed public support. One way to achieve public understanding and support is through effective communication of the risks, benefits, and uncertainties of local flooding hazards and adaptation methods. In order to develop these communications effectively, the city and its partners will need to know what knowledge and attitudes the residents of Pittsburgh already hold about flood risks. Here we seek to (1) identify Pittsburgh residents' knowledge level, risk perception and attitudes towards flooding and storm water management, and (2) pre-test communications meant to inform and empower Pittsburghers about flood risks and adaptation strategies. We conduct a city-wide survey of 10,000 Pittsburgh renters and homeowners from four life situations: high risk, above poverty; high-risk, below poverty; low risk, above poverty; and low-risk, below poverty. Mixed media recruitment strategies (online and paper-based solicitations guided/organized by community organizations) assist in reaching all subpopulations. Preliminary results suggest participants know what stormwater runoff is, but have a weak understanding of how stormwater interacts with natural and built systems. Furthermore, although participants have a good understanding of the difference between green and gray infrastructure, this does not translate into a change in their willingness to pay for green infrastructure adaptation. This suggests additional communications about flood risks and adaptation strategies.

Children at risk: 2. Risk Factors and Clinic Utilization

DTIC Science & Technology

1989-03-27

family size. While birth order was gener- RCMAS scores were conditional upon children’s clinic status ally not related to children’s symptoms, family...dysfunction. birth order are more frequently referred to clinical settings, 810 J. Am. Acad. Child Adolesc. Psychiatry. 29:5, September 1990 CHILDREN AT RISK

Effect of RAAS blockers on adverse clinical outcomes in high CVD risk subjects with atrial fibrillation: A meta-analysis and systematic review of randomized controlled trials.

PubMed

Chaugai, Sandip; Sherpa, Lhamo Yanchang; Sepehry, Amir A; Arima, Hisatomi; Wang, Dao Wen

2016-06-01

Recent studies have demonstrated that atrial fibrillation significantly increases the risk of adverse clinical outcomes in high cardiovascular disease risk subjects. Application of renin-angiotensin-aldosterone system blockers for prevention of recurrence of atrial fibrillation and adverse clinical outcomes in subjects with atrial fibrillation is a theoretically appealing concept. However, results of clinical trials evaluating the effect of renin-angiotensin-aldosterone blockers on adverse clinical outcomes in high cardiovascular disease risk subjects with atrial fibrillation remain inconclusive.A pooled study of 6 randomized controlled trials assessing the efficacy of renin-angiotensin-aldosterone blockers on subjects with atrial fibrillation was performed.A total of 6 randomized controlled trials enrolled a total of 53,510 patients followed for 1 to 5 years. RAAS blockade therapy was associated with 14% reduction in the incidence of heart failure (OR: 0.86, [95%CI: 0.76- 0.97], P=0.018) and 17% reduction in the incidence of CVE (OR: 0.83, [95%CI: 0.70-0.99], P = 0.038). The corresponding decline in absolute risk against heart failure (ARR: 1.4%, [95%CI: 0.2-2.6%], P = 0.018) and CVE (ARR: 3.5%, [95%CI: 0.0-6.9%], P = 0.045) in the AF group was much higher than the non-AF group for heart failure (ARR: 0.4%, [95%CI: 0.0-0.7%], P = 0.057) and CVE (ARR: 1.6%, [95%CI: -0.1% to 3.3%], P = 0.071). No significant effect was noted on all-cause or cardiovascular mortality, stroke, or myocardial infarction.This study suggests that RAAS blockade offers protection against heart failure and cardiovascular events in high cardiovascular disease risk subjects with atrial fibrillation.

Solemnity: A Clinical Risk Index for Iron Deficient Infants.

ERIC Educational Resources Information Center

Honig, Alice Sterling; Oski, Frank A.

1984-01-01

Studies four groups of infants with iron deficiency but without anemia in an attempt to discover behavioral signs that can be used to index high-risk probability for iron deficiency. Solemnity in well-attached infants is suggested as a clinical sign to indicate the need for biochemical screening for iron deficiency. (AS)

Detection of High-Risk Atherosclerotic Plaque

PubMed Central

Fleg, Jerome L.; Stone, Gregg W.; Fayad, Zahi A.; Granada, Juan F.; Hatsukami, Thomas S.; Kolodgie, Frank D.; Ohayon, Jacques; Pettigrew, Roderic; Sabatine, Marc S.; Tearney, Guillermo; Waxman, Sergio; Domanski, Michael J.; Srinivas, Pothur R.; Narula, Jagat

2013-01-01

The leading cause of major morbidity and mortality in most countries around the world is atherosclerotic cardiovascular disease, most commonly caused by thrombotic occlusion of a high-risk coronary plaque resulting in myocardial infarction or cardiac death, or embolization from a high-risk carotid plaque resulting in stroke. The lesions prone to result in such clinical events are termed vulnerable or high-risk plaques, and their identification may lead to the development of pharmacological and mechanical intervention strategies to prevent such events. Autopsy studies from patients dying of acute myocardial infarction or sudden death have shown that such events typically arise from specific types of atherosclerotic plaques, most commonly the thin-cap fibroatheroma. However, the search in human beings for vulnerable plaques before their becoming symptomatic has been elusive. Recently, the PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree) study demonstrated that coronary plaques that are likely to cause future cardiac events, regardless of angiographic severity, are characterized by large plaque burden and small lumen area and/or are thin-cap fibroatheromas verified by radiofrequency intravascular ultrasound imaging. This study opened the door to identifying additional invasive and noninvasive imaging modalities that may improve detection of high-risk atherosclerotic lesions and patients. Beyond classic risk factors, novel biomarkers and genetic profiling may identify those patients in whom noninvasive imaging for vulnerable plaque screening, followed by invasive imaging for risk confirmation is warranted, and in whom future pharmacological and/or device-based focal or regional therapies may be applied to improve long-term prognosis. PMID:22974808

At-risk studies and clinical antecedents of psychosis, bipolar disorder and depression: a scoping review in the context of clinical staging.

PubMed

Hartmann, Jessica A; Nelson, Barnaby; Ratheesh, Aswin; Treen, Devi; McGorry, Patrick D

2018-06-04

Identifying young people at risk of developing serious mental illness and identifying predictors of onset of illness has been a focus of psychiatric prediction research, particularly in the field of psychosis. Work in this area has facilitated the adoption of the clinical staging model of early clinical phenotypes, ranging from at-risk mental states to chronic and severe mental illness. It has been a topic of debate if these staging models should be conceptualised as disorder-specific or transdiagnostic. In order to inform this debate and facilitate cross-diagnostic discourse, the present scoping review provides a broad overview of the body of literature of (a) longitudinal at-risk approaches and (b) identified antecedents of (homotypic) illness progression across three major mental disorders [psychosis, bipolar disorder (BD) and depression], and places these in the context of clinical staging. Stage 0 at-risk conceptualisations (i.e. familial high-risk approaches) were identified in all three disorders. However, formalised stage 1b conceptualisations (i.e. ultra-high-risk approaches) were only present in psychosis and marginally in BD. The presence of non-specific and overlapping antecedents in the three disorders may support a general staging model, at least in the early stages of severe psychotic or mood disorders.

Society of Behavioral Medicine supports implementation of high quality lung cancer screening in high-risk populations.

PubMed

Watson, Karriem S; Blok, Amanda C; Buscemi, Joanna; Molina, Yamile; Fitzgibbon, Marian; Simon, Melissa A; Williams, Lance; Matthews, Kameron; Studts, Jamie L; Lillie, Sarah E; Ostroff, Jamie S; Carter-Harris, Lisa; Winn, Robert A

2016-12-01

The Society of Behavioral Medicine (SBM) supports the United States Preventive Services Task Force (USPSTF) recommendation of low-dose computed tomography (LDCT) screening of the chest for eligible populations to reduce lung cancer mortality. Consistent with efforts to translate research findings into real-world settings, SBM encourages health-care providers and health-care systems to (1) integrate evidence-based tobacco treatment as an essential component of LDCT-based lung cancer screening, (2) examine the structural barriers that may impact screening uptake, and (3) incorporate shared decision-making as a clinical platform to facilitate consultations and engagement with individuals at high risk for lung cancer about the potential benefits and harms associated with participation in a lung cancer screening program. We advise policy makers and legislators to support screening in high-risk populations by continuing to (1) expand access to high quality LDCT-based screening among underserved high-risk populations, (2) enhance cost-effectiveness by integrating evidence-based tobacco treatments into screening in high-risk populations, and (3) increase funding for research that explores implementation science and increased public awareness and access of diverse populations to participate in clinical and translational research.

Clinical and neurophysiological risk factors for falls in patients with bilateral vestibulopathy.

PubMed

Schniepp, Roman; Schlick, Cornelia; Schenkel, Fabian; Pradhan, Cauchy; Jahn, Klaus; Brandt, Thomas; Wuehr, Max

2017-02-01

Patients with bilateral vestibular failure (BVF) exhibit imbalance when standing and walking that is linked to a higher fall risk. The purpose of this study was to identify risk factors for falls in BVF. We therefore systematically investigated the interrelationship of clinical and demographic characteristics, gait impairments, and the fall frequency of these patients. Clinical and demographic characteristics as well as quantitative measures of gait performance on a pressure-sensitive gait carpet were collected from 55 patients with different etiologies of BVF. Clinical and demographic data as well as spatiotemporal gait characteristics were used for ANOVA testing and a logistic regression model with categorized fall events as dependent variables. The impairment of peripheral vestibular function, duration of disease, and the overall gait status were not associated with the history of falls in patients with BVF. In contrast, the most predictive factors for falls in BVF were an increase in temporal gait variability, especially at slow walking speeds (p < 0.001; OR = 1.3), and the presence of a concomitant peripheral neuropathy (p < 0.045; OR = 3.6). BVF patients with a high risk of falling exhibit specific gait alterations in a speed-dependent manner. In particular, increased gait fluctuations during slow walking are most predictive for an increased fall risk. The presence of a concomitant peripheral neuropathy further critically impairs postural stability in these patients. Clinical assessment of both these aspects is therefore important to identify those patients at a particularly high fall risk and to initiate preventive procedures early.

Non-localization and localization ROC analyses using clinically based scoring

NASA Astrophysics Data System (ADS)

Paquerault, Sophie; Samuelson, Frank W.; Myers, Kyle J.; Smith, Robert C.

2009-02-01

We are investigating the potential for differences in study conclusions when assessing the estimated impact of a computer-aided detection (CAD) system on readers' performance. The data utilized in this investigation were derived from a multi-reader multi-case observer study involving one hundred mammographic background images to which fixed-size and fixed-intensity Gaussian signals were added, generating a low- and high-intensity signal sets. The study setting allowed CAD assessment in two situations: when CAD sensitivity was 1) superior or 2) lower than the average reader. Seven readers were asked to review each set in the unaided and CAD-aided reading modes, mark and rate their findings. Using this data, we studied the effect on study conclusion of three clinically-based receiver operating characteristic (ROC) scoring definitions. These scoring definitions included both location-specific and non-location-specific rules. The results showed agreement in the estimated impact of CAD on the overall reader performance. In the study setting where CAD sensitivity is superior to the average reader, the mean difference in AUC between the CAD-aided read and unaided read was 0.049 (95%CIs: -0.027; 0.130) for the image scoring definition that is based on non-location-specific rules, and 0.104 (95%CIs: 0.036; 0.174) and 0.090 (95%CIs: 0.031; 0.155) for image scoring definitions that are based on location-specific rules. The increases in AUC were statistically significant for the location-specific scoring definitions. It was further observed that the variance on these estimates was reduced when using the location-specific scoring definitions compared to that using a non-location-specific scoring definition. In the study setting where CAD sensitivity is equivalent or lower than the average reader, the mean differences in AUC are slightly above 0.01 for all image scoring definitions. These increases in AUC were not statistical significant for any of the image scoring definitions

Episodic memory functions in first episode psychosis and clinical high risk individuals.

PubMed

Greenland-White, Sarah E; Ragland, J Daniel; Niendam, Tara A; Ferrer, Emilio; Carter, Cameron S

2017-10-01

Individuals with schizophrenia have disproportionate memory impairments when encoding relational versus item-specific information, and when using recollection versus familiarity during retrieval. It is unclear whether this pattern is unique to people with chronic schizophrenia, or if it occurs in individuals after a first episode of psychosis (FE), or when at clinical high-risk for psychosis (CHR). We administered the Relational and Item-Specific Memory task (RiSE) to 22 CHR, 101 FE, and 58 typically developing (TD) participants. We examined group differences in item and relational encoding, and familiarity-based and recollection-based retrieval using parametric analysis and structural equation modeling (SEM). Longitudinal data allowed us to examine relations between baseline RiSE performance and change in clinical symptoms at 1-year follow-up in the FE group. Groups did not differ on familiarity. FE and CHR groups were equally impaired on overall recognition accuracy. Although recollection was impaired in both FE and CHR groups following relational encoding, only the FE group had impaired recollection following item encoding. SEM showed atypical relationships between familiarity and recollection, as well as familiarity and item recognition for both the FE and CHR groups. For FE individuals, better baseline recognition accuracy predicted less severe negative symptoms at 1-year follow-up. Impaired relational and recollective memory may reflect neurodevelopmental abnormalities predating conversion to psychosis. These memory deficits appear related to negative symptom changes. In contrast, item specific recollection deficits appear to occur after the development of full psychosis. Familiarity appears to be a relatively preserved memory function across the psychosis spectrum. Copyright © 2017 Elsevier B.V. All rights reserved.

Psychosocial and clinical risk factor profiles in managers.

PubMed

Kentner, M; Ciré, L; Scholl, J

2000-06-01

Over the past 10 years the IAS Foundation has performed more than 15,000 PREVENT check-ups on managers. In addition to a comprehensive clinical program of preventive examinations, the main emphasis is placed on extensive counseling. This counseling centres not only on personal behaviour patterns affecting the individual's health, but also on the psychomental capabilities of the patient within the context of the psychosocial stresses in managerial positions. Three cross-sectional studies examined: (1) the major cardiovascular risk factors (n = 974), (2) the psychosocial structure (n = 2,800) and (3) the relationships between clinical risk factors and psychological structural features (n = 200). According to expectations, managers showed somewhat lower cardiovascular risk levels than did other professional groups. However, nearly 70% of them reported various unspecific, psychovegetative complaints. Managers were subdivided into four psychological types, each representing roughly one quarter of the series: Type 1: anxiety, tension (20.5%); Type 2: repression, lack of self-control (22.2%); Type 3: challenge, ambition, self-control (27.6%); Type 4: healthy living, with self-control (29.7%). Type 3 resembles most closely classic type A behaviour and is seen in a good quarter of the overall cohort. This may indicate that not only people showing type A behaviour are predestined to occupy managerial positions, but that people with a type B structure also take up managerial positions. It is, however, in particular the type B behavioural patterns that are also associated with increased psychovegetative complaints. The relationships between psychosocial structural variables and clinical risk factors such as hypercholesteremia and high blood pressure are not very strong. Occupational health measures in organisations should also be established for managers, as they present an important employee group within the enterprise. In addition to examining them for cardiovascular risks

Identifying high risk medications causing potential drug-drug interactions in outpatients: A prescription database study based on an online surveillance system.

PubMed

Toivo, T M; Mikkola, J A V; Laine, K; Airaksinen, M

2016-01-01

Drug-drug interactions (DDIs) are a significant cause for adverse drug events (ADEs). DDIs are often predictable and preventable, but their prevention and management require systematic service development. Most DDI studies focus on interaction rates in hospitalized patients. Less is known of DDIs in outpatients, particularly how community pharmacists could contribute to DDI management by applying their surveillance systems for identifying high-risk medications. The study was related to the implementation of the first online DDI surveillance system in Finnish community pharmacies. The goal was to demonstrate how community pharmacies can utilize their prospective surveillance system 1) for identifying high risk medications causing potential DDIs in outpatients, 2) for collaborative service development with local physicians, and 3) for academic risk management research purposes. All DDI alerts given by the online surveillance system were collected during a one-month period in 16 out of 17 University Pharmacy outlets in Finland, covering approximately 10% of the national outpatient prescription volume. The surveillance system was based on the FASS database, which categorizes DDIs into four classes (A-D) according to their clinical significance. Potential drug-drug DDIs were analyzed for 276,891 dispensed community pharmacy prescriptions. Potential DDIs were associated with 10.8%, or 31,110 of these prescriptions. Clinically significant interaction alerts categorized as FASS classes D (most severe, should be avoided) and C (clinically significant but controllable) were associated with 0.5% and 7.0% of the prescriptions, respectively. Methotrexate and warfarin had the highest risk of causing potentially serious (class D) interactions. These interaction alerts were most frequently between methotrexate and NSAIDs and warfarin and NSAIDs. In general, NSAIDs were the most commonly interacting drugs in this study. This study demonstrates that community pharmacies can actively

Evaluation of the clinical performance of the Abbott RealTime High-Risk HPV for carcinogenic HPV detection.

PubMed

Halfon, Philippe; Benmoura, Dominique; Agostini, Aubert; Khiri, Hacene; Penaranda, Guillaume; Martineau, Agnes; Blanc, Bernard

2010-08-01

Abbott RealTime (RT) High-Risk (HR) HPV assay is a new qualitative real-time polymerase chain reaction (PCR) based assay for the detection of 14 HR HPV DNA. The assay can differentiate between the infection by HPV 16, HPV 18 and non-HPV 16/18 types through the distinct fluorescent labels on the type specific probes. To evaluate the clinical performance of the Abbott RT HR HPV test, in comparison with biopsy, Hybrid Capture II (HCII), and Linear Array (LA), for detection of high-grade disease (CIN2+). The study population consisted of 143 women who were included in three referral gynecology clinics in Marseilles (France) between March 2007 and June 2008. The clinical performance of the RT HR HPV assay, performed on the fully automated m2000 system, was compared with HCII and LA. HR HPV positivity rate was similar for all tests (Abbott RT HR HPV and HCII, 62%, and LA 63%). All tests had high sensitivities and negative predictive values for CIN2+ detection (>90%). The agreement between HCII and Abbott RT HR HPV, and between HCII and LA were 93% (k=0.85) and 96% (k=0.91) respectively. As expected, HPV16 or HPV18 positivity was greater in advanced grades of disease, especially in CIN2+ patients: 85% in CIN2+ vs. 33% in clinical performance of the Abbott RT HR HPV assay is good and closely correlated with the two other assays. The automation and ability to identify type 16 and 18 make this a very attractive option for HPV testing in laboratories and potentially provides improved patient management. Copyright 2010. Published by Elsevier B.V.

Meningitis With a Negative Cerebrospinal Fluid Gram Stain in Adults: Risk Classification for an Adverse Clinical Outcome

PubMed Central

Khoury, Nabil T.; Hossain, Md Monir; Wootton, Susan H.; Salazar, Lucrecia; Hasbun, Rodrigo

2012-01-01

Objective To derive and validate a risk score for an adverse clinical outcome in adults with meningitis and a negative cerebrospinal fluid (CSF) Gram stain. Patients and Methods We conducted a retrospective study of 567 adults from Houston, Texas, with meningitis evaluated between January 1, 2005, and January 1, 2010. The patients were divided into derivation (N=292) and validation (N=275) cohorts. An adverse clinical outcome was defined as a Glasgow Outcome Scale score of 4 or less. Results Of the 567 patients, 62 (11%) had an adverse clinical outcome. A predictive model was created using 3 baseline variables that were independently associated with an adverse clinical outcome (P<.05): age greater than 60 years, abnormal findings on neurologic examination (altered mental status, focal neurologic deficits, or seizures), and CSF glucose level of less than 2.4975 mmol/L (to convert CSF glucose to mmol/L, multiply by 0.05551). The model classified patients into 2 categories of risk for an adverse clinical outcome—derivation sample: low risk, 0.6% and high risk, 32.8%; P<.001; and validation sample: low risk, 0.5% and high risk, 21.1%; P<.001. Conclusion Adults with meningitis and a negative CSF Gram stain can be accurately stratified for the risk of an adverse clinical outcome using clinical variables available at presentation. PMID:23218086

Redefining High-Risk Prostate Cancer Based on Distant Metastases and Mortality After High-Dose Radiotherapy With Androgen Deprivation Therapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tendulkar, Rahul D., E-mail: tendulr@ccf.org; Reddy, Chandana A.; Stephans, Kevin L.

2012-03-15

Purpose: Modern outcomes of high-dose external beam radiotherapy (EBRT) with androgen deprivation therapy (ADT) for high-risk (HR) prostate cancer are not well described. Methods and Materials: We identified 585 patients who met HR criteria by 2010 National Comprehensive Cancer Network guidelines, who were treated with EBRT consisting of {>=}74 Gy from 1996 to 2008 at Cleveland Clinic, of whom 95% received ADT. We analyzed biochemical relapse-free survival (bRFS), distant metastases-free survival (DMFS), and prostate cancer-specific mortality (PCSM). Results: The median EBRT dose was 78 Gy, and median ADT duration was 6 months. At 10 years, the bRFS was 50.2%, themore » DMFS was 71.6%, and the PCSM was 14.4%. On multivariate analysis, significant predictors of bRFS were biopsy Gleason score (bGS) of 8 to 10, stage T3, and prostate-specific antigen (PSA) concentration; predictors of DMFS were bGS of 8 to 10 and stage T3; the only predictor of PCSM was bGS of 8 to 10. The duration of ADT was not predictive of any endpoint. We identified an unfavorable high-risk (UHR) group of stage T1-T2 tumors consisting of bGS of 8 with PSA of >10 ng/ml or bGS of 9 to 10 with any PSA level; the remaining clinically localized cancers comprised the favorable high-risk (FHR) group. Comparing FHR, UHR, and stage T3 groups, the DMFS rates were 81.4%, 57.8%, and 59.1% (p < 0.0001), and the PCSM rates were 7.5%, 28.4%, and 20.6% at 10 years, respectively (p = 0.006). Conclusion: A bGS of 8 to 10 is the strongest predictor of bRFS, DMFS, and PCSM after high-dose EBRT with ADT. The duration of ADT did not correlate with outcome. Future studies should account for the heterogeneity in HR prostate cancer.« less

Relation between Kidney Length and Cardiovascular and Renal Risk in High-Risk Patients

PubMed Central

van der Sande, Nicolette G.C.; Visseren, Frank L.J.; van der Graaf, Yolanda; Nathoe, Hendrik M.; de Borst, Gert Jan; Leiner, Tim

2017-01-01

Background and objectives Kidney length is often measured during routine abdominal ultrasonography and may be of use to identify patients at high vascular and renal risk. We aimed to explore patient characteristics related to kidney length, from which reference values were derived, and evaluate the relationship between kidney length and the risk of cardiovascular events and ESRD in high-risk patients. Design, setting, participants, & measurements The study population consisted of 10,251 patients with clinical manifest arterial disease or vascular risk factors included in the Second Manifestations of ARTerial disease (SMART) Study cohort between 1996 and 2014. Linear regression was used to explore patient characteristics of kidney length. The relationship between kidney length and cardiovascular events (myocardial infarction, stroke, and cardiovascular mortality), all-cause mortality, and ESRD was analyzed using Cox regression. Kidney length was analyzed in tertiles, using the second tertile as the reference category. Results Kidney length was strongly correlated with body surface area (2.04 mm; 95% confidence interval [95% CI], 1.95 to 2.13 per 0.1 m2 increase) and eGFR (1.62 mm; 95% CI, 1.52 to 1.73 per 10 ml/min per 1.73 m2 increase). During the median follow-up of 6.3 years, 1317 patients experienced a cardiovascular event, including 711 myocardial infarctions, 369 strokes, and 735 vascular cause deaths. A total of 1462 patients died of any cause and 52 patients developed ESRD. Irrespective of eGFR, patients in the third tertile of kidney length (11.7–16.1 cm) were at higher risk of cardiovascular mortality (hazard ratio, 1.33; 95% CI, 1.05 to 1.67) and cardiovascular events (hazard ratio, 1.28; 95% CI, 1.09 to 1.50). Patients in the first tertile of kidney length (7.8–10.8 cm) were not at higher risk of cardiovascular adverse events. Conclusions Large kidney length is related to higher risk of cardiovascular events and mortality in high-risk patients

Relation between Kidney Length and Cardiovascular and Renal Risk in High-Risk Patients.

PubMed

van der Sande, Nicolette G C; Visseren, Frank L J; van der Graaf, Yolanda; Nathoe, Hendrik M; de Borst, Gert Jan; Leiner, Tim; Blankestijn, Peter J

2017-06-07

Kidney length is often measured during routine abdominal ultrasonography and may be of use to identify patients at high vascular and renal risk. We aimed to explore patient characteristics related to kidney length, from which reference values were derived, and evaluate the relationship between kidney length and the risk of cardiovascular events and ESRD in high-risk patients. The study population consisted of 10,251 patients with clinical manifest arterial disease or vascular risk factors included in the Second Manifestations of ARTerial disease (SMART) Study cohort between 1996 and 2014. Linear regression was used to explore patient characteristics of kidney length. The relationship between kidney length and cardiovascular events (myocardial infarction, stroke, and cardiovascular mortality), all-cause mortality, and ESRD was analyzed using Cox regression. Kidney length was analyzed in tertiles, using the second tertile as the reference category. Kidney length was strongly correlated with body surface area (2.04 mm; 95% confidence interval [95% CI], 1.95 to 2.13 per 0.1 m 2 increase) and eGFR (1.62 mm; 95% CI, 1.52 to 1.73 per 10 ml/min per 1.73 m 2 increase). During the median follow-up of 6.3 years, 1317 patients experienced a cardiovascular event, including 711 myocardial infarctions, 369 strokes, and 735 vascular cause deaths. A total of 1462 patients died of any cause and 52 patients developed ESRD. Irrespective of eGFR, patients in the third tertile of kidney length (11.7-16.1 cm) were at higher risk of cardiovascular mortality (hazard ratio, 1.33; 95% CI, 1.05 to 1.67) and cardiovascular events (hazard ratio, 1.28; 95% CI, 1.09 to 1.50). Patients in the first tertile of kidney length (7.8-10.8 cm) were not at higher risk of cardiovascular adverse events. Large kidney length is related to higher risk of cardiovascular events and mortality in high-risk patients, irrespective of eGFR. Kidney length may serve as a clinical marker to further identify patients at

Update on contemporary management of clinically localized renal cell carcinoma.

PubMed

Jorns, J J; Thiel, D D; Castle, E P

2012-12-01

Renal cell carcinoma (RCC) continues to increase in incidence with the largest increase manifesting in small, organ-confined tumors. This review outlines the epidemiology and current data pertaining to the management of clinically-localized RCC. In this manuscript, the current data outlining the benefit of nephron sparing to the overall survival of the patient is described. The data pertaining to minimally invasive nephron sparing is also explained in detail. From laparoscopic and robotic partial nephrectomy to watchful waiting and percutaneous ablation, the urologist is continually assaulted with new data for the management of clinically-localized RCC. The data can be confusing, and much of it is conflicting. The addition of new scoring systems or nomograms may aid in predicting which therapy would be most beneficial in certain patient groups. New scoring systems may also predict the difficulty of surgical resection and predict surgical complications. The limitations of the data pertaining to the management of clinically-localized RCC are also outlined.

Melanoma survivors at high risk of developing new primary disease: a qualitative examination of the factors that contribute to patient satisfaction with clinical care.

PubMed

McLoone, J K; Watts, K J; Menzies, S W; Barlow-Stewart, K; Mann, G J; Kasparian, N A

2013-09-01

Providing ongoing clinical care that adequately addresses patients' medical, psychosocial and information needs is challenging, particularly for patient groups at increased risk of developing life-threatening disease such as malignant melanoma. This study examined a model of clinical care developed by the High Risk Clinic (HRC) of the Sydney Melanoma Diagnostic Centre in relation to patient satisfaction. Semi-structured telephone interviews were conducted and analyzed using the framework of Miles and Huberman, and themes were organized using the qualitative software package, QSR NVivo8. Twenty HRC patients participated in the study (nine men, 11 women; mean age 57.6 years, age range 34-74 years; response rate 91%). Satisfaction with clinical care at the HRC was high. Factors contributing to patient satisfaction included: rapid and regular access to physicians who were perceived by participants as experts, the development of confidence and trust in one's treating doctor, and a sense of being cared about and understood by one's healthcare team. Although one-third of the participants reported some inconveniences in attending the clinic, these were viewed as minor difficulties and not significant barriers to care. Formal psychological support was not sought or expected by participants, although many expressed long-standing melanoma-related fears and concerns. Accessible, expert medical attention, delivered in a patient-centered manner was integral to melanoma survivors' satisfaction with clinical management. Appropriate referrals to psychological support may further increase satisfaction with clinical care. Copyright © 2013 John Wiley & Sons, Ltd.

Comparison of outcomes for MR-guided versus CT-guided high-dose-rate interstitial brachytherapy in women with locally advanced carcinoma of the cervix.

PubMed

Kamran, Sophia C; Manuel, Matthias M; Cho, Linda P; Damato, Antonio L; Schmidt, Ehud J; Tempany, Clare; Cormack, Robert A; Viswanathan, Akila N

2017-05-01

The purpose was to compare local control (LC), overall survival (OS) and dose to the organs at risk (OAR) in women with locally advanced cervical cancer treated with MR-guided versus CT-guided interstitial brachytherapy (BT). 56 patients (29 MR, 27 CT) were treated with high-dose-rate (HDR) interstitial BT between 2005-2015. The MR patients had been prospectively enrolled on a Phase II clinical trial. Data were analyzed using Kaplan-Meier (K-M) and Cox proportional hazards statistical modeling in JMP® & R®. Median follow-up time was 19.7months (MR group) and 18.4months (CT group). There were no statistically significant differences in patient age at diagnosis, histology, percent with tumor size >4cm, grade, FIGO stage or lymph node involvement between the groups. Patients in the MR group had more lymphovascular involvement compared to patients in the CT group (p<0.01). When evaluating plans generated, there were no statistically significant differences in median cumulative dose to the high-risk clinical target volume or the OAR. 2-year K-M LC rates for MR-based and CT-based treatments were 96% and 87%, respectively (log-rank p=0.65). At 2years, OS was significantly better in the MR-guided cohort (84% vs. 56%, p=0.036). On multivariate analysis, squamous histology was associated with longer OS (HR 0.23, 95% CI 0.07-0.72) in a model with MR BT (HR 0.35, 95% CI 0.08-1.18). There was no difference in toxicities between CT and MR BT. In this population of locally advanced cervical-cancer patients, MR-guided HDR BT resulted in estimated 96% 2-year local control and excellent survival and toxicity rates. Copyright © 2017 Elsevier Inc. All rights reserved.

Comparison of outcomes for MR-guided versus CT-guided high-dose-rate interstitial brachytherapy in women with locally advanced carcinoma of the cervix

PubMed Central

Kamran, Sophia C.; Manuel, Matthias M.; Cho, Linda P.; Damato, Antonio L.; Schmidt, Ehud J.; Tempany, Clare; Cormack, Robert A.; Viswanathan, Akila N.

2017-01-01

Objective The purpose was to compare local control (LC), overall survival (OS) and dose to the organs at risk (OAR) in women with locally advanced cervical cancer treated with MR-guided versus CT-guided interstitial brachytherapy (BT). Methods 56 patients (29 MR, 27 CT) were treated with high-dose-rate (HDR) interstitial BT between 2005–2015. The MR patients had been prospectively enrolled on a Phase II clinical trial. Data were analyzed using Kaplan-Meier (K-M) and Cox proportional hazards statistical modeling in JMP® & R®. Results Median follow-up time was 19.7 months (MR group) and 18.4 months (CT group). There were no statistically significant differences in patient age at diagnosis, histology, percent with tumor size >4 cm, grade, FIGO stage or lymph node involvement between the groups. Patients in the MR group had more lymphovascular involvement compared to patients in the CT group (p<0.01). When evaluating plans generated, there were no statistically significant differences in median cumulative dose to the high-risk clinical target volume or the OAR. 2-year K-M LC rates for MR-based and CT-based treatments were 96% and 87%, respectively (log-rank p=0.65). At 2 years, OS was significantly better in the MR-guided cohort (84% vs. 56%, p=0.036). On multivariate analysis, squamous histology was associated with longer OS (HR 0.23, 95% CI 0.07–0.72) in a model with MR BT (HR 0.35, 95% CI 0.08–1.18). Conclusion In this population of locally advanced cervical-cancer patients, MR-guided HDR BT resulted in estimated 96% 2-year local control and excellent early survival rates. Squamous cell histology was the most significant predictor for survival. PMID:28318644

[Local communalization of clinical records between the municipal community hospital and local medical institutes by using information technology].

PubMed

Iijima, Shohei; Shinoki, Keiji; Ibata, Takeshi; Nakashita, Chisako; Doi, Seiko; Hidaka, Kumi; Hata, Akiko; Matsuoka, Mio; Waguchi, Hideko; Mito, Saori; Komuro, Ryutaro

2012-12-01

We introduced the electronic health record system in 2002. We produced a community medical network system to consolidate all medical treatment information from the local institute in 2010. Here, we report on the present status of this system that has been in use for the previous 2 years. We obtained a private server, set up a virtual private network(VPN)in our hospital, and installed dedicated terminals to issue an electronic certificate in 50 local institutions. The local institute applies for patient agreement in the community hospital(hospital designation style). They are then entitled to access the information of the designated patient via this local network server for one year. They can access each original medical record, sorted on the basis of the medical attendant and the chief physician; a summary of hospital stay; records of medication prescription; and the results of clinical examinations. Currently, there are approximately 80 new registrations and accesses per month. Information is provided in real time allowing up to date information, helping prescribe the medical treatment at the local institute. However, this information sharing system is read-only, and there is no cooperative clinical pass system. Therefore, this system has a limit to meet the demand for cooperation with the local clinics.

Risk Factors for Esophageal Fistula Associated With Chemoradiotherapy for Locally Advanced Unresectable Esophageal Cancer

PubMed Central

Tsushima, Takahiro; Mizusawa, Junki; Sudo, Kazuki; Honma, Yoshitaka; Kato, Ken; Igaki, Hiroyasu; Tsubosa, Yasuhiro; Shinoda, Masayuki; Nakamura, Kenichi; Fukuda, Haruhiko; Kitagawa, Yuko

2016-01-01

Abstract Esophageal fistula is a critical adverse event in patients treated with chemoradiotherapy (CRT) for locally advanced esophageal cancer. However, risk factors associated with esophageal fistula formation in patients receiving CRT have not yet been elucidated. We retrospectively analyzed data obtained from 140 patients who were enrolled in a phase II/III trial comparing low-dose cisplatin with standard-dose cisplatin administered in combination with 5-flurouracil and concomitant radiotherapy. Inclusion criteria were performance status (PS) 0 to 2 and histologically proven thoracic esophageal cancer clinically diagnosed as T4 and/or unresectable lymph node metastasis for which definitive CRT was applicable. Risk factors for esophageal fistula were examined with univariate analysis using Fisher exact test and multivariate analysis using logistic regression models. Esophageal fistula was observed in 31 patients (22%). Of these, 6 patients developed fistula during CRT. Median time interval between the date of CRT initiation and that of fistula diagnosis was 100 days (inter quartile range, 45–171). Esophageal stenosis was the only significant risk factor for esophageal fistula formation both in univariate (P = 0.026) and in multivariate analyses (odds ratio, 2.59; 95% confidence interval, 1.13–5.92, P = 0.025). Other clinicopathological factors, namely treatment arm, age, sex, PS, primary tumor location, T stage, lymph node invasion to adjacent organs, blood cell count, albumin level, and body mass index, were not risk factors fistula formation. Esophageal stenosis was a significant risk factor for esophageal fistula formation in patients treated with CRT for unresectable locally advanced thoracic esophageal squamous cell carcinoma. PMID:27196482

Localized scleroderma: a clinical study at a single center in Korea.

PubMed

Noh, Jung Won; Kim, Jinseok; Kim, Jae-Wang

2013-08-01

Localized scleroderma (morphea) is a rare autoimmune disease limited to the skin, characterized by cutaneous fibrosing and obstructive vasculopathy. Localized scleroderma may invade into the subcutaneous fat layer and cause permanent functional disability. Because of its rarity, there have been few clinical surveys of patients with localized scleroderma in Korea. The aim of this study was to elucidate the clinical presentation, serological data, and clinical outcomes of localized scleroderma. This was a retrospective survey conducted by reviewing available medical records during a 7 year-period from 2004 to 2010 in a single medical center in Jeju Island, South Korea. In total 43 patients with localized scleroderma were included. Localized scleroderma occurred primarily in females (female to male ratio 2.6 : 1.0). Most patients were between 10 and 29 years of age and the mean age at diagnosis was 26.2 years. Plaque (51.2%) and linear morphea (37.2%) were most common. No case was associated with systemic scleroderma (systemic sclerosis). The most common site of plaque morphea was the trunk (47.8%). In the linear type, the most common site was head-neck (52.9%). Fluorescent antinuclear antibody was positive in 23.3% of all cases. Treatment included systemic corticosteroids, colchicine, anti-malarial agents, D-penicillamine or intralesional triamcinolone injection. Clinical improvement, including significant and partial response, was seen in only 62.8% of treated patients. Localized scleroderma is a chronic inflammatory condition confined to the skin. In order to exclude other conditions, thorough history taking, physical examination, serologic studies and histopathologic examinations should be conducted. © 2013 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

Localized Scleroderma, Systemic Sclerosis and Cardiovascular Risk: A Danish Nationwide Cohort Study.

PubMed

Hesselvig, Jeanette Halskou; Kofoed, Kristian; Wu, Jashin J; Dreyer, Lene; Gislason, Gunnar; Ahlehoff, Ole

2018-03-13

Recent findings indicate that patients with systemic sclerosis have an increased risk of cardiovascular disease. To determine whether patients with systemic sclerosis or localized scleroderma are at increased risk of cardiovascular disease, a cohort study of the entire Danish population aged ≥ 18 and ≤ 100 years was conducted, followed from 1997 to 2011 by individual-level linkage of nationwide registries. Multivariable adjusted Cox regression models were used to estimate the hazard ratios (HRs) for a composite cardiovascular disease endpoint. A total of 697 patients with localized scleroderma and 1,962 patients with systemic sclerosis were identified and compared with 5,428,380 people in the reference population. In systemic sclerosis, the adjusted HR was 2.22 (95% confidence interval 1.99-2.48). No association was seen between patients with localized scleroderma and cardiovascular disease. In conclusion, systemic sclerosis is a significant cardiovascular disease risk factor, while patients with localized scleroderma are not at increased risk of cardiovascular disease.

Hypersensitivity lo local anesthetics.

PubMed

Grzanka, Alicja; Wasilewska, Iwona; Śliwczyńska, Magdalena; Misiołek, Hanna

2016-01-01

Using local anaesthetics in daily practice, particularly by anaesthetists and dentists, is connected with the risk of side effects. Therefore, the observation of side effects, carrying out detailed research (according to the chart proposed in this study) and conducting specialist examinations is of the highest importance. There is a variety of side effects that could occur during local anaesthesia procedures, with the intensity ranging from clinically unimportant to life threatening. Clinicians' major concerns are the appearance of various hypersensitivity reactions, including anaphylaxis. Healthcare providers responsible for the administration of local anaesthetics should be able to detect hypersensitivity reactions to implement appropriate treatment and then choose highly selected diagnostic procedures. The final diagnosis should be based on specific medical history; documentation, including a description of the case and measurement of tryptase activity; skin tests; and provocation trials. Screening tests are not recommended in populations without hypersensitivity to local anaesthestics in their medical history.

Predicting high-risk preterm birth using artificial neural networks.

PubMed

Catley, Christina; Frize, Monique; Walker, C Robin; Petriu, Dorina C

2006-07-01

A reengineered approach to the early prediction of preterm birth is presented as a complimentary technique to the current procedure of using costly and invasive clinical testing on high-risk maternal populations. Artificial neural networks (ANNs) are employed as a screening tool for preterm birth on a heterogeneous maternal population; risk estimations use obstetrical variables available to physicians before 23 weeks gestation. The objective was to assess if ANNs have a potential use in obstetrical outcome estimations in low-risk maternal populations. The back-propagation feedforward ANN was trained and tested on cases with eight input variables describing the patient's obstetrical history; the output variables were: 1) preterm birth; 2) high-risk preterm birth; and 3) a refined high-risk preterm birth outcome excluding all cases where resuscitation was delivered in the form of free flow oxygen. Artificial training sets were created to increase the distribution of the underrepresented class to 20%. Training on the refined high-risk preterm birth model increased the network's sensitivity to 54.8%, compared to just over 20% for the nonartificially distributed preterm birth model.

Brief assessment of food insecurity accurately identifies high-risk US adults.

PubMed

Gundersen, Craig; Engelhard, Emily E; Crumbaugh, Amy S; Seligman, Hilary K

2017-06-01

To facilitate the introduction of food insecurity screening into clinical settings, we examined the test performance of two-item screening questions for food insecurity against the US Department of Agriculture's Core Food Security Module. We examined sensitivity, specificity and accuracy of various two-item combinations of questions assessing food insecurity in the general population and high-risk population subgroups. 2013 Current Population Survey December Supplement, a population-based US survey. All survey participants from the general population and high-risk subgroups. The test characteristics of multiple two-item combinations of questions assessing food insecurity had adequate sensitivity (>97 %) and specificity (>70 %) for widespread adoption as clinical screening measures. We recommend two specific items for clinical screening programmes based on their widespread current use and high sensitivity for detecting food insecurity. These items query how often the household 'worried whether food would run out before we got money to buy more' and how often 'the food that we bought just didn't last and we didn't have money to get more'. The recommended items have sensitivity across high-risk population subgroups of ≥97 % and a specificity of ≥74 % for food insecurity.

Assessing Local Risk of Rifampicin-Resistant Tuberculosis in KwaZulu-Natal, South Africa Using Lot Quality Assurance Sampling.

PubMed

Heidebrecht, Christine L; Podewils, Laura J; Pym, Alexander; Mthiyane, Thuli; Cohen, Ted

2016-01-01

KwaZulu-Natal (KZN) has the highest burden of notified multidrug-resistant tuberculosis (MDR TB) and extensively drug-resistant (XDR) TB cases in South Africa. A better understanding of spatial heterogeneity in the risk of drug-resistance may help to prioritize local responses. Between July 2012 and June 2013, we conducted a two-way Lot Quality Assurance Sampling (LQAS) study to classify the burden of rifampicin (RIF)-resistant TB among incident TB cases notified within the catchment areas of seven laboratories in two northern and one southern district of KZN. Decision rules for classification of areas as having either a high- or low-risk of RIF resistant TB (based on proportion of RIF resistance among all TB cases) were based on consultation with local policy makers. We classified five areas as high-risk and two as low-risk. High-risk areas were identified in both Southern and Northern districts, with the greatest proportion of RIF resistance observed in the northernmost area, the Manguzi community situated on the Mozambique border. Our study revealed heterogeneity in the risk of RIF resistant disease among incident TB cases in KZN. This study demonstrates the potential for LQAS to detect geographic heterogeneity in areas where access to drug susceptibility testing is limited.

Assessing Local Risk of Rifampicin-Resistant Tuberculosis in KwaZulu-Natal, South Africa Using Lot Quality Assurance Sampling

PubMed Central

Heidebrecht, Christine L.; Podewils, Laura J.; Pym, Alexander; Mthiyane, Thuli; Cohen, Ted

2016-01-01

Background KwaZulu-Natal (KZN) has the highest burden of notified multidrug-resistant tuberculosis (MDR TB) and extensively drug-resistant (XDR) TB cases in South Africa. A better understanding of spatial heterogeneity in the risk of drug-resistance may help to prioritize local responses. Methods Between July 2012 and June 2013, we conducted a two-way Lot Quality Assurance Sampling (LQAS) study to classify the burden of rifampicin (RIF)-resistant TB among incident TB cases notified within the catchment areas of seven laboratories in two northern and one southern district of KZN. Decision rules for classification of areas as having either a high- or low-risk of RIF resistant TB (based on proportion of RIF resistance among all TB cases) were based on consultation with local policy makers. Results We classified five areas as high-risk and two as low-risk. High-risk areas were identified in both Southern and Northern districts, with the greatest proportion of RIF resistance observed in the northernmost area, the Manguzi community situated on the Mozambique border. Conclusion Our study revealed heterogeneity in the risk of RIF resistant disease among incident TB cases in KZN. This study demonstrates the potential for LQAS to detect geographic heterogeneity in areas where access to drug susceptibility testing is limited. PMID:27050561

Care zoning in a psychiatric intensive care unit: strengthening ongoing clinical risk assessment.

PubMed

Mullen, Antony; Drinkwater, Vincent; Lewin, Terry J

2014-03-01

To implement and evaluate the care zoning model in an eight-bed psychiatric intensive care unit and, specifically, to examine the model's ability to improve the documentation and communication of clinical risk assessment and management. Care zoning guides nurses in assessing clinical risk and planning care within a mental health context. Concerns about the varying quality of clinical risk assessment prompted a trial of the care zoning model in a psychiatric intensive care unit within a regional mental health facility. The care zoning model assigns patients to one of 3 'zones' according to their clinical risk, encouraging nurses to document and implement targeted interventions required to manage those risks. An implementation trial framework was used for this research to refine, implement and evaluate the impact of the model on nurses' clinical practice within the psychiatric intensive care unit, predominantly as a quality improvement initiative. The model was trialled for three months using a pre- and postimplementation staff survey, a pretrial file audit and a weekly file audit. Informal staff feedback was also sought via surveys and regular staff meetings. This trial demonstrated improvement in the quality of mental state documentation, and clinical risk information was identified more accurately. There was limited improvement in the quality of care planning and the documentation of clinical interventions. Nurses' initial concerns over the introduction of the model shifted into overall acceptance and recognition of the benefits. The results of this trial demonstrate that the care zoning model was able to improve the consistency and quality of risk assessment information documented. Care planning and evaluation of associated outcomes showed less improvement. Care zoning remains a highly applicable model for the psychiatric intensive care unit environment and is a useful tool in guiding nurses to carry out routine patient risk assessments. © 2013 John Wiley & Sons

Study Shows Aspirin Reduces Colorectal Cancer in Those at High Risk

Cancer.gov

Findings from the first large clinical trial of its kind indicate that taking high doses of aspirin daily for at least 2 years substantially reduces the risk of colorectal cancer among people at increased risk of the disease.

Clinical Manifestation and Risk Factors of Tuberculosis Infection in Malaysia: Case Study of a Community Clinic

PubMed Central

Shanmuganathan, Rohan; Shanmuganathan, Indra Devi

2015-01-01

Introduction: The main aim of this study was to describe the clinical manifestation of tuberculosis infection cases in Malaysia and to determine the individual risk factors for their occurrence. Methodology: The study adopted a quantitative research approach with use of descriptive statistical approach. The study setting was a community clinic which treats walk in patients who are mainly living and working in the surrounding areas. The study was conducted for a period of one year. All tuberculosis patients who sought treatment in the clinic during the time were included in this study. The total number of cases was 40. Data was collected from the medical records of the tuberculosis patients. The risk factors selected for investigation were demographic characteristics of age and sex, personal habits such as smoking, drug use and alcohol and presence of diseases such as human immunodeficiency virus positive (HIV+), diabetes mellitus, cancer, cyanotic heart disease, renal failure and steroid use. Results: Patients in the age group ranging from 41 to 50 years had the highest incidence of the infection. Smoking appears to be the most important risk factor for contracting followed by drug abuse, HIV+ infection and diabetes mellitus. Conclusions: People with diseases such as diabetes mellitus and HIV that are high risk factors for TB should be screened for TB so that early detection and intervention is possible. Educational programs should be carried out to create awareness among the at risk groups. PMID:25946947

Clinical manifestation and risk factors of tuberculosis infection in Malaysia: case study of a community clinic.

PubMed

Shanmuganathan, Rohan; Subramaniam, Indra Devi

2015-01-01

The main aim of this study was to describe the clinical manifestation of tuberculosis infection cases in Malaysia and to determine the individual risk factors for their occurrence. The study adopted a quantitative research approach with use of descriptive statistical approach. The study setting was a community clinic which treats walk in patients who are mainly living and working in the surrounding areas. The study was conducted for a period of one year. All tuberculosis patients who sought treatment in the clinic during the time were included in this study. The total number of cases was 40. Data was collected from the medical records of the tuberculosis patients. The risk factors selected for investigation were demographic characteristics of age and sex, personal habits such as smoking, drug use and alcohol and presence of diseases such as human immunodeficiency virus positive (HIV+), diabetes mellitus, cancer, cyanotic heart disease, renal failure and steroid use. Patients in the age group ranging from 41 to 50 years had the highest incidence of the infection. Smoking appears to be the most important risk factor for contracting followed by drug abuse, HIV+ infection and diabetes mellitus. People with diseases such as diabetes mellitus and HIV that are high risk factors for TB should be screened for TB so that early detection and intervention is possible. Educational programs should be carried out to create awareness among the at risk groups.

Therapeutic risk management of the suicidal patient: augmenting clinical suicide risk assessment with structured instruments.

PubMed

Homaifar, Beeta; Matarazzo, Bridget; Wortzel, Hal S

2013-09-01

This column is the second in a series presenting a model for therapeutic risk management of the suicidal patient. As discussed in the first part of the series, the model involves several elements including augmenting clinical risk assessment with structured instruments, stratifying risk in terms of both severity and temporality, and developing and documenting a safety plan. This column explores in more detail how to augment clinical risk assessment with structured instruments. Unstructured clinical interviews have the potential to miss important aspects of suicide risk assessment. By augmenting the free-form clinical interview with structured instruments that demonstrate reliability and validity, a more nuanced and multifaceted approach to suicide risk assessment is achieved. Incorporating structured instruments into practice also serves a medicolegal function, since these instruments may become a living part of the medical record, establishing baseline levels of suicidal thoughts and behaviors and facilitating future clinical determinations regarding safety needs. We describe several instruments used in a multidisciplinary suicide consultation service, each of which has demonstrated relevance to suicide risk assessment and screening, ease of administration, and strong psychometric properties. In addition, we emphasize the importance of viewing suicide risk assessment as an ongoing process rather than as a singular event. Finally, we discuss special considerations in the evolving practice of risk assessment.

Can Image-Defined Risk Factors Predict Surgical Complications in Localized Neuroblastoma?

PubMed

Yoneda, Akihiro; Nishikawa, Masanori; Uehara, Shuichiro; Oue, Takaharu; Usui, Noriaki; Inoue, Masami; Fukuzawa, Masahiro; Okuyama, Hiroomi

2016-02-01

Image-defined risk factors (IDRFs) have been propounded for predicting the surgical risks associated with localized neuroblastoma (NB) since 2009. In 2011, a new guideline (NG) for assessing IDRFs was published. According to the NG, the situation in which "the tumor is only in contact with renal vessels," should be considered to be "IDRF-present." Previously, this situation was diagnosed as "IDRF absent." In this study, we evaluated the IDRFs in localized NB patients to clarify the predictive capability of IDRFs for surgical complications, as well as the usefulness of the NG. Materials and A total of 107 localized patients with NB were included in this study. The enhanced computed tomography and magnetic resonance images from the time of their diagnoses were evaluated by a single radiologist. We also analyzed the association of clinical factors, including the IDRFs (before and after applying the NG), with surgical complications. Of the 107 patients, 33 and 74 patients were diagnosed as IDRF-present (OP group), and IDRF-absent (ON group) before the NG, respectively. According to the NG, there were 76 and 31 patients who were classified as IDRF-present (NP group) and IDRF absent (NN group), respectively. Thus, 43 (40%) patients in the ON group were reassigned to the NP group after the NG. Surgical complications were observed in 17 of 82 patients who underwent surgical resection. Of the patients who underwent secondary operations, surgical complication rates were 55% in the OP group and 44% in the NP group. According to a univariate analysis, non-INSS 1, IDRFs before and after the NG and secondary operations were significantly associated with surgical complications. In a multivariate analysis, non-INSS 1 status and IDRFs after the NG were significantly associated with surgical complications. Georg Thieme Verlag KG Stuttgart · New York.

Quality assurance study of caries risk assessment performance by clinical faculty members in a school of dentistry.

PubMed

Rechmann, Peter; Featherstone, John D B

2014-09-01

The goal of this quality assurance study was to explore the decision making of clinical faculty members at the University of California, San Francisco School of Dentistry predoctoral dental clinic in terms of caries risk level assignment using the caries risk assessment (CRA) as part of the Caries Management by Risk Assessment (CAMBRA) concept. This research was done in part to determine if additional training and calibration were needed for these faculty members. The study tested the reliability and reproducibility of the caries risk levels assigned by different clinical teachers who completed CRA forms for simulated patients. In the first step, five clinical teachers assigned caries risk levels for thirteen simulated patients. Six months later, the same five plus an additional nine faculty members assigned caries risk levels to the same thirteen simulated and nine additional cases. While the intra-examiner reliability with weighted kappa strength of agreement was very high, the inter-examiner agreements with a gold standard were on average only moderate. In total, 20 percent of the presented high caries risk cases were underestimated at caries levels too low, even when obvious caries disease indicators were present. This study suggests that more consistent training and calibration of clinical faculty members as well as students are needed.

Clinically Relevant Cytotoxic Immune Cell Signatures and Clonal Expansion of T Cell Receptors in High-risk MYCN-not-amplified Human Neuroblastoma.

PubMed

Wei, Jun S; Kuznetsov, Igor B; Zhang, Shile; Song, Young K; Asgharzadeh, Shahab; Sindiri, Sivasish; Wen, Xinyu; Patidar, Rajesh; Nagaraj, Sushma; Walton, Ashley; Guidry Auvil, Jaime M; Gerhard, Daniela S; Yuksel, Aysen; Catchpoole, Daniel R; Hewitt, Stephen M; Sondel, Paul M; Seeger, Robert C; Maris, John M; Khan, Javed

2018-05-21

High-risk neuroblastoma is an aggressive disease. DNA sequencing studies have revealed a paucity of actionable genomic alterations and a low mutation burden, posing challenges to develop effective novel therapies. We used RNA sequencing (RNA-seq) to investigate the biology of this disease including a focus on tumor-infiltrating lymphocytes (TILs). We performed deep RNA-seq on pre-treatment diagnostic tumors from 129 high-risk and 21 low- or intermediate-risk patients with neuroblastomas. We used single-sample gene set enrichment analysis to detect gene expression signatures of TILs in tumors and examined their association with clinical and molecular parameters including patient outcome. The expression profiles of 190 additional pre-treatment diagnostic neuroblastomas, a neuroblastoma tissue microarray, and T-cell receptor (TCR) sequencing were used to validate our findings. We found that MYCN -not-amplified ( MYCN -NA) tumors had significant higher cytotoxic TIL signatures compared to MYCN -amplified ( MYCN -A) tumors. A reported MYCN-activation-signature was significantly associated with poor outcome for high-risk patients with MYCN -NA tumors; however, a subgroup of these patients who had elevated activated NK cells, CD8+ T-cells, and cytolytic signatures showed improved outcome and expansion of infiltrating T-cell receptor (TCR) clones. Furthermore, we observed up-regulation of immune exhaustion marker genes, indicating an immune suppressive microenvironment in these neuroblastomas. Conclusions: This study provides evidence that RNA signatures of cytotoxic TIL are associated with the presence of activated NK-/T-cells and improved outcomes in high-risk neuroblastoma patients harboring MYCN -NA tumors. Our findings suggest that these high-risk patients with MYCN -NA neuroblastoma may benefit from additional immunotherapies incorporated into the current therapeutic strategies. Copyright ©2018, American Association for Cancer Research.

Comparison of the analytical and clinical performances of Abbott RealTime High Risk HPV, Hybrid Capture 2, and DNA Chip assays in gynecology patients.

PubMed

Park, Seungman; Kang, Youjin; Kim, Dong Geun; Kim, Eui-Chong; Park, Sung Sup; Seong, Moon-Woo

2013-08-01

The detection of high-risk (HR) HPV in cervical cancer screening is important for early diagnosis of cervical cancer or pre-cancerous lesions. We evaluated the analytical and clinical performances of 3 HR HPV assays in Gynecology patients. A total of 991 specimens were included in this study: 787 specimens for use with a Hybrid Capture 2 (HC2) and 204 specimens for a HPV DNA microarray (DNA Chip). All specimens were tested using an Abbott RealTime High Risk HPV assay (Real-time HR), PGMY PCR, and sequence analysis. Clinical sensitivities for severe abnormal cytology (severe than high-grade squamous intraepithelial lesion) were 81.8% for Real-time HR, 77.3% for HC2, and 66.7% for DNA Chip, and clinical sensitivities for severe abnormal histology (cervical intraepithelial neoplasia grade 2+) were 91.7% for HC2, 87.5% for Real-time HR, and 73.3% for DNA Chip. As compared to results of the sequence analysis, HC2, Real-time HR, and DNA Chip showed concordance rates of 94.3% (115/122), 90.0% (117/130), and 61.5% (16/26), respectively. The HC2 assay and Real-time HR assay showed comparable results to each other in both clinical and analytical performances, while the DNA Chip assay showed poor clinical and analytical performances. The Real-time HR assay can be a good alternative option for HR HPV testing with advantages of allowing full automation and simultaneous genotyping of HR types 16 and 18. Copyright © 2013 Elsevier Inc. All rights reserved.

Aberrant temporal behavior of mismatch negativity generators in schizophrenia patients and subjects at clinical high risk for psychosis.

PubMed

Kim, Minah; Cho, Kang Ik Kevin; Yoon, Youngwoo Bryan; Lee, Tae Young; Kwon, Jun Soo

2017-02-01

Although disconnection syndrome has been considered a core pathophysiologic mechanism of schizophrenia, little is known about the temporal behavior of mismatch negativity (MMN) generators in individuals with schizophrenia or clinical high risk (CHR) for psychosis. MMN was assessed in 29 schizophrenia patients, 40 CHR subjects, and 47 healthy controls (HCs). Individual realistic head models and the minimum L2 norm algorithm were used to generate a current source density (CSD) model of MMN. The strength and time course of MMN CSD activity were calculated separately for the frontal and temporal cortices and were compared across brain regions and groups. Schizophrenia patients and CHR subjects displayed lower MMN CSD strength than HCs in both the temporal and frontal cortices. We found a significant time delay in MMN generator activity in the frontal cortex relative to that in the temporal cortex in HCs. However, the sequential temporo-frontal activities of MMN generators were disrupted in both the schizophrenia and CHR groups. Impairments and altered temporal behavior of MMN multiple generators were observed even in individuals at risk for psychosis. These findings suggest that aberrant MMN generator activity might be helpful in revealing the pathophysiology of schizophrenia. Copyright © 2016 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.

Orthodontics and enamel demineralization: clinical study of risk factors.

PubMed

Benkaddour, Asmae; Bahije, Loubna; Bahoum, Asmae; Zaoui, Fatima

2014-12-01

The appearance of white spots on the vestibular surface of teeth fitted with brackets has been described as one of the potential iatrogenic effects of orthodontic treatment. These enamel demineralizations, more commonly known as "white spot lesions" (WSL), lead in some rare cases to the creation of true cavities, causing both esthetic and functional problems. The aim of our retrospective clinical study was to evaluate the incidence of the appearance of these WSL in a Moroccan orthodontic population and to determine possible associations with a number of risk factors. The study was based on intraoral photographs of a pool of 69 patients who underwent orthodontic treatment with or without extractions in the DFO unit of the Rabat CCDT (Center for dental consultation and treatment). Patients with prostheses or WSL before the beginning of the study were excluded. Digital start- and end-of-treatment photos for each patient were compared by a single operator looking for the appearance of WSL on the vestibular surfaces of the incisors, canines, premolars and first molars. WSL were classed according to three degrees of severity: slight, severe and cavitation. Data were processed using SPSS 13.0 software. The results of the study showed that the prevalence of WSL in the sample was 66.7%, with a highly significant predominance of localization in the premolar/molar segment and in patients with poor oral hygiene. Poor oral and dental hygiene was identified as the most important risk factor for the development of white spots during multibracket orthodontic treatment. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Long-term Survival and Toxicity in Patients Treated With High-Dose Intensity Modulated Radiation Therapy for Localized Prostate Cancer

DOE Office of Scientific and Technical Information (OSTI.GOV)

Spratt, Daniel E.; Pei, Xin; Yamada, Josh

2013-03-01

Purpose: To report long-term survival and toxicity outcomes with the use of high-dose intensity modulated radiation therapy (IMRT) to 86.4 Gy for patients with localized prostate cancer. Methods and Materials: Between August 1997 and December 2008, 1002 patients were treated to a dose of 86.4 Gy using a 5-7 field IMRT technique. Patients were stratified by prognostic risk group based on National Comprehensive Cancer Network risk classification criteria. A total of 587 patients (59%) were treated with neoadjuvant and concurrent androgen deprivation therapy. The median follow-up for the entire cohort was 5.5 years (range, 1-14 years). Results: For low-, intermediate-,more » and high-risk groups, 7-year biochemical relapse-free survival outcomes were 98.8%, 85.6%, and 67.9%, respectively (P<.001), and distant metastasis-free survival rates were 99.4%, 94.1%, and 82.0% (P<.001), respectively. On multivariate analysis, T stage (P<.001), Gleason score (P<.001), and >50% of initial biopsy positive core (P=.001) were predictive for distant mestastases. No prostate cancer-related deaths were observed in the low-risk group. The 7-year prostate cancer-specific mortality (PCSM) rates, using competing risk analysis for intermediate- and high-risk groups, were 3.3% and 8.1%, respectively (P=.008). On multivariate analysis, Gleason score (P=.004), percentage of biopsy core positivity (P=.003), and T-stage (P=.033) were predictive for PCSM. Actuarial 7-year grade 2 or higher late gastrointestinal and genitourinary toxicities were 4.4% and 21.1%, respectively. Late grade 3 gastrointestinal and genitourinary toxicity was experienced by 7 patients (0.7%) and 22 patients (2.2%), respectively. Of the 427 men with full potency at baseline, 317 men (74%) retained sexual function at time of last follow-up. Conclusions: This study represents the largest cohort of patients treated with high-dose radiation to 86.4 Gy, using IMRT for localized prostate cancer, with the longest follow-up to

Intensive Auditory Cognitive Training Improves Verbal Memory in Adolescents and Young Adults at Clinical High Risk for Psychosis.

PubMed

Loewy, Rachel; Fisher, Melissa; Schlosser, Danielle A; Biagianti, Bruno; Stuart, Barbara; Mathalon, Daniel H; Vinogradov, Sophia

2016-07-01

Individuals at clinical high risk (CHR) for psychosis demonstrate cognitive impairments that predict later psychotic transition and real-world functioning. Cognitive training has shown benefits in schizophrenia, but has not yet been adequately tested in the CHR population. In this double-blind randomized controlled trial, CHR individuals (N = 83) were given laptop computers and trained at home on 40 hours of auditory processing-based exercises designed to target verbal learning and memory operations, or on computer games (CG). Participants were assessed with neurocognitive tests based on the Measurement and Treatment Research to Improve Cognition in Schizophrenia initiative (MATRICS) battery and rated on symptoms and functioning. Groups were compared before and after training using a mixed-effects model with restricted maximum likelihood estimation, given the high study attrition rate (42%). Participants in the targeted cognitive training group showed a significant improvement in Verbal Memory compared to CG participants (effect size = 0.61). Positive and Total symptoms improved in both groups over time. CHR individuals showed patterns of training-induced cognitive improvement in verbal memory consistent with prior observations in schizophrenia. This is a particularly vulnerable domain in individuals at-risk for psychosis that predicts later functioning and psychotic transition. Ongoing follow-up of this cohort will assess the durability of training effects in CHR individuals, as well as the potential impact on symptoms and functioning over time. Clinical Trials Number: NCT00655239. URL: https://clinicaltrials.gov/ct2/show/NCT00655239?term=vinogradov&rank=5. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center 2016.

Localized scleroderma en coup de sabre in the Neurology Clinic.

PubMed

Pinho, João; Rocha, João; Sousa, Filipa; Macedo, Cristiana; Soares-Fernandes, João; Cerqueira, João; Maré, Ricardo; Lourenço, Esmeralda; Pereira, João

2016-07-01

Localized scleroderma en coup de sabre (LScs) is a form of localized scleroderma thought to be an autoimmune disorder. Central nervous system involvement is not rare and neurological manifestations include seizures, focal neurological deficits, headache and neuropsychiatric changes. Patients attending the Neurology Clinic with the final diagnosis of LScs with neurological manifestations were identified and clinical and imagiological records reviewed. Five patients (0.024%) had LScs with neurological involvement, presenting with transient focal neurologic deficits, seizures, headache or migraine with aura. Neuroimaging studies confirmed localized skin depression and showed bone thinning, white matter lesions, brain calcifications, sulcal effacement and meningeal enhancement. Three patients experienced clinical improvement after immunosuppressive therapy, and in two of these patients neuroimaging findings also improved. Recognizing typical dermatologic changes is keystone for the diagnosis of LScs with neurological involvement. It is a diagnosis of exclusion and extensive etiological diagnostic evaluation should be performed. Treatment options, including conservative follow-up or immunosuppressive therapy, should be carefully considered. Copyright © 2016 Elsevier B.V. All rights reserved.

Prostate Specific Antigen (PSA) as Predicting Marker for Clinical Outcome and Evaluation of Early Toxicity Rate after High-Dose Rate Brachytherapy (HDR-BT) in Combination with Additional External Beam Radiation Therapy (EBRT) for High Risk Prostate Cancer.

PubMed

Ecke, Thorsten H; Huang-Tiel, Hui-Juan; Golka, Klaus; Selinski, Silvia; Geis, Berit Christine; Koswig, Stephan; Bathe, Katrin; Hallmann, Steffen; Gerullis, Holger

2016-11-10

High-dose-rate brachytherapy (HDR-BT) with external beam radiation therapy (EBRT) is a common treatment option for locally advanced prostate cancer (PCa). Seventy-nine male patients (median age 71 years, range 50 to 79) with high-risk PCa underwent HDR-BT following EBRT between December 2009 and January 2016 with a median follow-up of 21 months. HDR-BT was administered in two treatment sessions (one week interval) with 9 Gy per fraction using a planning system and the Ir192 treatment unit GammaMed Plus iX. EBRT was performed with CT-based 3D-conformal treatment planning with a total dose administration of 50.4 Gy with 1.8 Gy per fraction and five fractions per week. Follow-up for all patients was organized one, three, and five years after radiation therapy to evaluate early and late toxicity side effects, metastases, local recurrence, and prostate-specific antigen (PSA) value measured in ng/mL. The evaluated data included age, PSA at time of diagnosis, PSA density, BMI (body mass index), Gleason score, D'Amico risk classification for PCa, digital rectal examination (DRE), PSA value after one/three/five year(s) follow-up (FU), time of follow-up, TNM classification, prostate volume, and early toxicity rates. Early toxicity rates were 8.86% for gastrointestinal, and 6.33% for genitourinary side effects. Of all treated patients, 84.81% had no side effects. All reported complications in early toxicity were grade 1. PSA density at time of diagnosis ( p = 0.009), PSA on date of first HDR-BT ( p = 0.033), and PSA on date of first follow-up after one year ( p = 0.025) have statistical significance on a higher risk to get a local recurrence during follow-up. HDR-BT in combination with additional EBRT in the presented design for high-risk PCa results in high biochemical control rates with minimal side-effects. PSA is a negative predictive biomarker for local recurrence during follow-up. A longer follow-up is needed to assess long-term outcome and toxicities.

Clinical risk and depression (continuing education credit).

PubMed

Sharkey, S

1997-01-22

This article provides information and guidance to nurses on clinical risks in mental health, particularly that of depression. It relates to UKCC professional development category: Reducing risk and Care enhancement.

Relation between cannabis use and subcortical volumes in people at clinical high risk of psychosis

PubMed Central

Buchy, Lisa; Mathalon, Daniel H.; Cannon, Tyrone D.; Cadenhead, Kristin S.; Cornblatt, Barbara A.; McGlashan, Thomas H.; Perkins, Diana O.; Seidman, Larry J.; Tsuang, Ming T.; Walker, Elaine F.; Woods, Scott W.; Bearden, Carrie E.; Addington, Jean

2016-01-01

Among people at genetic risk of schizophrenia, those who use cannabis show smaller thalamic and hippocampal volumes. We evaluated this relationship in people at clinical high risk (CHR) of psychosis. The Alcohol and Drug Use Scale was used to identify 132 CHR cannabis users, the majority of whom were non-dependent cannabis users, 387 CHR non-users, and 204 healthy control non-users, and all participants completed magnetic resonance imaging scans. Volumes of the thalamus, hippocampus and amygdala were extracted with FreeSurfer, and compared across groups. Comparing all CHR participants with healthy control participants revealed no significant differences in volumes of any ROI. However, when comparing CHR users to CHR non-users, a significant ROI × Cannabis group effect emerged: CHR users showed significantly smaller amygdala compared to CHR non-users. However, when limiting analysis to CHR subjects who reported using alcohol at a ‘use without impairment’ severity level, the amygdala effect was non-significant; rather, smaller hippocampal volumes were seen in CHR cannabis users compared to non-users. Controlling statistically for effects of alcohol and tobacco use rendered all results non-significant. These results highlight the importance of controlling for residual confounding effects of other substance use when examining the relationship between cannabis use and neural structure. PMID:27289213

Do travel clinic visitors read information on sexual risk abroad in travel health brochures?

PubMed Central

Croughs, Mieke; de Gouw, Annemarie; Remmen, Roy; Van den Ende, Jef

2016-01-01

Background: A substantial proportion of travel clinic visitors have sexual encounters while abroad. Hence, guidelines on travel health recommend discussing sexual risk in a pre-travel consultation. However, previous studies showed that it often is not discussed. Although travel clinic visitors usually do receive written information on sexual risk abroad, few data are available on whether this information is read. Therefore, this prospective cohort study in travel clinic visitors was performed. Methods: Travel clinic visitors were invited to complete a questionnaire after return from their journey. Results: A total of 130 travellers (55%) responded. Half of them recorded they read the information on sexual risk. Male gender (OR 9.94 95% CI 3.12 – 31.63) and ‘travelling with others’ (OR 2.7 95% CI 1.29 – 5.78) were significant independent predictors of reading the information on sexual risk. High risk travellers, i.e. those travelling without a steady partner, were less likely to have read it. Although websites and apps were mentioned as better methods of providing information, none of the participants visited the websites on sexual behaviour and sexually transmitted infections recommended in the travel health brochure. Conclusion: Only half of travel clinic visitors read information on sexual risk in the health brochure received in the clinic and none of them visited the related websites mentioned in the brochure. Further research to identify the most effective way to inform travellers about sexual risk is needed. PMID:28989499

Do travel clinic visitors read information on sexual risk abroad in travel health brochures?

PubMed

Croughs, Mieke; de Gouw, Annemarie; Remmen, Roy; Van den Ende, Jef

2017-01-01

A substantial proportion of travel clinic visitors have sexual encounters while abroad. Hence, guidelines on travel health recommend discussing sexual risk in a pre-travel consultation. However, previous studies showed that it often is not discussed. Although travel clinic visitors usually do receive written information on sexual risk abroad, few data are available on whether this information is read. Therefore, this prospective cohort study in travel clinic visitors was performed. Travel clinic visitors were invited to complete a questionnaire after return from their journey. A total of 130 travellers (55%) responded. Half of them recorded they read the information on sexual risk. Male gender (OR 9.94 95% CI 3.12 - 31.63) and 'travelling with others' (OR 2.7 95% CI 1.29 - 5.78) were significant independent predictors of reading the information on sexual risk. High risk travellers, i.e. those travelling without a steady partner, were less likely to have read it. Although websites and apps were mentioned as better methods of providing information, none of the participants visited the websites on sexual behaviour and sexually transmitted infections recommended in the travel health brochure. Only half of travel clinic visitors read information on sexual risk in the health brochure received in the clinic and none of them visited the related websites mentioned in the brochure. Further research to identify the most effective way to inform travellers about sexual risk is needed.

Use of clinical risk factors to identify postmenopausal women with vertebral fractures.

PubMed

Tobias, J H; Hutchinson, A P; Hunt, L P; McCloskey, E V; Stone, M D; Martin, J C; Thompson, P W; Palferman, T G; Bhalla, A K

2007-01-01

Previous studies have been unable to identify risk factors for prevalent vertebral fractures (VF), which are suitable for use in selection strategies intended to target high-risk sub-groups for diagnostic assessment. However, these studies generally consisted of large epidemiology surveys based on questionnaires and were only able to evaluate a limited number of risk factors. Here, we investigated whether a stronger relationship exists with prevalent VF when conventional risk factors are combined with additional information obtained from detailed one-to-one assessment. Women aged 65-75 registered at four geographically distinct GP practices were invited to participate (n=1,518), of whom 540 attended for assessment as follows: a questionnaire asking about risk factors for osteoporosis such as height loss compared to age 25 and history of non-vertebral fracture (NVF), the get-up-and-go test, Margolis back pain score, measurement of wall-tragus and rib-pelvis distances, and BMD as measured by the distal forearm BMD. A lateral thoraco-lumbar spine X-ray was obtained, which was subsequently scored for the presence of significant vertebral deformities. Of the 509 subjects who underwent spinal radiographs, 37 (7.3%) were found to have one or more VF. Following logistic regression analysis, the four most predictive clinical risk factors for prevalent VF were: height loss (P=0.006), past NVF (P=0.004), history of back pain (P=0.075) and age (P=0.05). BMD was also significantly associated with prevalent VF (P=0.002), but its inclusion did not affect associations with other variables. Factors elicited from detailed one-to-one assessment were not related to the risk of one or more prevalent VFs. The area under ROC curves derived from these regressions, which suggested that models for prevalent VF had modest predictive accuracy, were as follows: 0.68 (BMD), 0.74 (four clinical risk factors above) and 0.78 (clinical risk factors + BMD). Analyses were repeated in relation to the

Local stakeholders' perception of landslide and flood risks in Iasi County, Romania

NASA Astrophysics Data System (ADS)

Ciprian Margarint, Mihai; Niculita, Mihai; Rosu, Lucian

2015-04-01

Risk perception is an important issue for an efficient management and mitigation measures of natural hazards and theirs negative consequences on social and economic activity. At administrative unit scale (LAU2), local stakeholders play an effective role in case of an emergency situation, regarding the warning and alerting the population, collaboration with specialized institution and managing material assistance during and after the crisis. In addition they are among the best connoisseurs of local community and places, and consequently they could substantial help the national level forces during emergency situations. These issues argues the high degree of responsibilities assigned to Romanian mayors, and is reflected in the legislation in terms of evaluation of damages produced and the management of natural hazards, like landslide and floods. Also their degree of awareness can assess more accurately the collective perception against the individual one. In this work we have assessed the local stakeholders' perception for natural risks in general, and particularly for landslides and floods. We have tested the discrepancies of the specific risks perception and an assessment of correspondence between scientific outputs versus the subjective judgement the administrative decision makers. This approach was based on a questionnaire which was applied in the summer of 2014, to all 98 mayors from Iasi County, north-east Romania. It contained 12 questions structured in a specific mode, from general to particular. The assessment of the answers provided from the commune halls, was realized with integration in a GIS environment of codes assigned to each question, and the overlay with the scientific outputs regarding landslide occurrence and susceptibility and floods risk maps. The differences between the outputs of the questionnaires and the scientific outputs of landslide and flood risk was further analyzed and interpreted. There were registered large variations of answers and

The "polyenviromic risk score": Aggregating environmental risk factors predicts conversion to psychosis in familial high-risk subjects.

PubMed

Padmanabhan, Jaya L; Shah, Jai L; Tandon, Neeraj; Keshavan, Matcheri S

2017-03-01

Young relatives of individuals with schizophrenia (i.e. youth at familial high-risk, FHR) are at increased risk of developing psychotic disorders, and show higher rates of psychiatric symptoms, cognitive and neurobiological abnormalities than non-relatives. It is not known whether overall exposure to environmental risk factors increases risk of conversion to psychosis in FHR subjects. Subjects consisted of a pilot longitudinal sample of 83 young FHR subjects. As a proof of principle, we examined whether an aggregate score of exposure to environmental risk factors, which we term a 'polyenviromic risk score' (PERS), could predict conversion to psychosis. The PERS combines known environmental risk factors including cannabis use, urbanicity, season of birth, paternal age, obstetric and perinatal complications, and various types of childhood adversity, each weighted by its odds ratio for association with psychosis in the literature. A higher PERS was significantly associated with conversion to psychosis in young, familial high-risk subjects (OR=1.97, p=0.009). A model combining the PERS and clinical predictors had a sensitivity of 27% and specificity of 96%. An aggregate index of environmental risk may help predict conversion to psychosis in FHR subjects. Copyright © 2016 Elsevier B.V. All rights reserved.

Contributions of early cortical processing and reading ability to functional status in individuals at clinical high risk for psychosis.

PubMed

Carrión, Ricardo E; Cornblatt, Barbara A; McLaughlin, Danielle; Chang, Jeremy; Auther, Andrea M; Olsen, Ruth H; Javitt, Daniel C

2015-05-01

There is a growing recognition that individuals at clinical high risk need intervention for functional impairments, along with emerging psychosis, as the majority of clinical high risk (CHR) individuals show persistent deficits in social and role functioning regardless of transition to psychosis. Recent studies have demonstrated reduced reading ability as a potential cause of functional disability in schizophrenia, related to underlying deficits in generation of mismatch negativity (MMN). The present study extends these findings to subjects at CHR. The sample consisted of 34 CHR individuals and 33 healthy comparison subjects (CNTLs) from the Recognition and Prevention (RAP) Program at the Zucker Hillside Hospital in New York. At baseline, reading measures were collected, along with MMN to pitch, duration, and intensity deviants, and measures of neurocognition, and social and role (academic/work) functioning. CHR subjects showed impairments in reading ability, neurocognition, and MMN generation, relative to CNTLs. Lower-amplitude MMN responses were correlated with worse reading ability, slower processing speed, and poorer social and role functioning. However, when entered into a simultaneous regression, only reduced responses to deviance in sound duration and volume predicted poor social and role functioning, respectively. Deficits in reading ability exist even prior to illness onset in schizophrenia and may represent a decline in performance from prior abilities. As in schizophrenia, deficits are related to impaired MMN generation, suggesting specific contributions of sensory-level impairment to neurocognitive processes related to social and role function. Copyright © 2015 Elsevier B.V. All rights reserved.

High-Risk Medication Use by Nursing Home Residents Before and After Hospitalization

PubMed Central

Stevenson, David G.; Dusetzina, Stacie B.; O’Malley, A. James; Mitchell, Susan L.; Zarowitz, Barbara J.; Chernew, Michael E.; Newhouse, Joseph P.; Huskamp, Haiden A.

2014-01-01

Background Two prominent challenges in nursing home care are ensuring appropriate medication use and achieving high quality care as residents transition from the hospital to the nursing home and back. Research about prescribing practices at this important clinical juncture is limited. Objective To analyze the use of high-risk medications by nursing home residents before and after being hospitalized. We define high-risk medications using the Beers criteria for potentially inappropriate medication use. Research Design, Subjects, Measures Using a dataset with Medicare claims for inpatient and skilled nursing facility stays, and pharmacy claims for all medications dispensed in the nursing home setting, we examine high-risk medication use for hospitalized nursing home residents before and after being hospitalized. Our study population includes 52,559 dual-eligible nursing home residents aged 65 and older who are hospitalized and then readmitted to the same nursing home in 2008. Our primary outcome of interest is the use of high-risk medications in the 30 days before hospitalization and the 30 days following readmission to the same nursing home. We define high-risk medications using the Beers criteria for potentially inappropriate medication use. Results Around one in five hospitalized nursing home residents (21%) used at least one high-risk medication the day before hospitalization. Among individuals with high-risk medication use at hospitalization, the proportion using these medications dropped to 45% after nursing home readmission but increased thereafter, to 59% by the end of the 30-day period. Conclusion We found moderate levels of high-risk medication use by hospitalized nursing home residents before and after their hospital stays, constituting an important clinical and policy challenge. PMID:25185637

Prevalence of high-risk human papilloma virus among women with hepatitis C virus before liver transplantation.

PubMed

Tarallo, P A; Smolowitz, J; Carriero, D; Tarallo, J; Siegel, A; Jia, H; Emond, J C

2013-08-01

We sought to assess the prevalence and risk factors for high-risk human papillomavirus (HPV) infection among female liver transplant (LT) candidates. Traditional health screening before LT listing has included Pap smear and is typically carried out by the patient's local provider. The prevalence of high-risk HPV in this population has not been studied. With Institutional Review Board approval, 62 LT candidates received a liquid-based Pap smear with high-risk HPV testing as part of their pre-transplant evaluation by a single provider. Clinical variables included age, ethnicity, insurance status, prior Pap smear, and HPV results, HPV risk factors including age of first intercourse, number of lifetime partners, last sexual activity, smoking, birth control pill use, history of sexually transmitted infections, human immunodeficiency virus status, immunosuppressive medication, medical diagnoses, prescribed medications, and history of hepatitis A, B, C, or D. The 62 women had a median age of 56 years, and 39% had high-risk behavior known to be associated with HPV. Ten of 62 patients (16.1%) had high-risk HPV at baseline screening, 5 of whom had atypical cytology. All of the patients who were positive for high-risk HPV had an etiology of hepatitis C virus (HCV) as the underlying cause of liver disease, with the majority (90%) having no history of high-risk behavior for HPV. In contrast, all patients with high-risk behavior who were HCV negative were HPV negative. Fisher's exact test demonstrated a statistically significant relationship between HPV and HCV; odds ratio = 24.4, 95% confidence interval, 1.4, 438.7, P-value = 0.0013. None of the other potential risk factors were associated with HPV in this cohort. In this study, we provide evidence of a strong association between HCV and HPV in LT candidates, which has not been previously reported. HPV positivity was observed in non-sexually active women, suggesting a reactivation of dormant HPV. An association between

[How to prevent hazards and to reduce risk in clinical trials?].

PubMed

Czarkowski, Marek

2008-12-01

Different stakeholders involved in clinical trials are exposed to hazards related with this biomedical research. Beside clinical trials participants other important stakeholders are: investigators, sponsors, centers and clinical research organizations. Hazard prevention needs effective methods of hazard disclosure and analysis. A reduction of risks related with clinical trials is possible due to education, training, inspections, research discipline and penalties. Effective ways of hazard elimination or hazard reduction should be developed as well. Education and training should be offered to all stakeholders but their forms and contents should be adapted to different types of stakeholders. Direct control of the clinical trials should be held by stakeholders conducting clinical trials and outside inspections should be done by other institutions like clinical research organizations, research ethics committees and The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Serious oversight is an absence of any independent inspection during a phase of publication of clinical trial results. We should not accept any exception from the golden rule that results of all clinical trials must be published. Indemnity for damages is a popular way of compensation for clinical trials participants. Investigators, sponsors and centers should have valid liability insurance. Drastic measures for reduction of risks in clinical trials are different kinds of penalties. They should prevent participation of unreliable stakeholders and promote those who respect regulations and high ethical standards.

Grandparents, parents, and grandchildren at high risk for depression: a three-generation study.

PubMed

Warner, V; Weissman, M M; Mufson, L; Wickramaratne, P J

1999-03-01

High-risk studies of psychiatric disorders in parents and offspring that include 3 generations are uncommon. Multigenerational studies can be clinically useful as they can provide information for risk prediction from one generation to another for the development of empirically based interventions. Using a high-risk design, this study examines the association of grandparent major depressive disorder (MDD) and parent MDD with psychopathology in grandchildren. Using Cox proportional hazards in a sample of 90 grandchildren at high and low risk for depression by virtue of their grandparents' and parents' depression status, the authors examined the risk for offspring depression and anxiety. Grandparent and parent MDD were associated with grandchild anxiety (relative risk [RR] = 5.51 and R = 3.09, respectively). Grandchildren with both a depressed parent and grandparent had the highest risk for anxiety. Parental MDD is associated with an increased risk for grandchild disruptive disorder (RR = 10.77). Forty-nine percent of the grandchildren in families in which both the parent and grandparent were depressed had some form of psychopathology. The grandchildren from those families were the most impaired. Prepubertal-onset anxiety disorder is a risk factor for the later development of clinically significant recurrent MDD across several generations of families at high risk for depression. Parental impaired functioning increases the risk for disruptive disorders. Children in families with multiple generations of depression are at particularly high risk for some form of psychopathology.

Recurrence risk of ictal asystole in epilepsy.

PubMed

Hampel, Kevin G; Thijs, Roland D; Elger, Christian E; Surges, Rainer

2017-08-22

To determine the recurrence risk of ictal asystole (IA) and its determining factors in people with epilepsy. We performed a systematic review of published cases with IA in 3 databases and additionally searched our local database for patients with multiple seizures simultaneously recorded with ECG and EEG and at least one IA. IA recurrence risk was estimated by including all seizures without knowledge of the chronological order. Various clinical features were assessed by an individual patient data meta-analysis. A random mixed effect logistic regression model was applied to estimate the average recurrence risk of IA. Plausibility of the calculated IA recurrence risk was checked by analyzing the local dataset with available information in chronological order. Eighty patients with 182 IA in 537 seizures were included. Recurrence risk of IA amounted to 40% (95% confidence interval [CI] 32%-50%). None of the clinical factors (age, sex, type and duration of epilepsy, hemispheric lateralization, duration of IA per patient) appeared to have a significant effect on the short-term recurrence risk of IA. When considering the local dataset only, IA recurrence risk was estimated to 30% (95% CI 14%-53%). Information whether IA coincided with symptoms (i.e., syncope) or not was given in 60 patients: 100 out of 142 IAs were symptomatic. Our data suggest that in case of clinically suspected IA, the recording of 1 or 2 seizures is not sufficient to rule out IA. Furthermore, the high short-term recurrence risk favors aggressive treatment, including pacemaker implantation if seizure freedom cannot be achieved. Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

Outcomes and predictive tests from a dedicated specialist clinic for women at high risk of preterm labour: A ten year audit.

PubMed

Hughes, Kelly; Sim, Shirlene; Roman, Alina; Michalak, Kasia; Kane, Stefan; Sheehan, Penelope

2017-08-01

Preterm birth continues to be a major cause of infant morbidity and mortality worldwide, but advances have recently been made in its prediction and prevention. A short cervix (<25 mm) in the second trimester on transvaginal ultrasound scan and fetal fibronectin are important predictive tests. For over ten years, the Preterm Labour Clinic at the Royal Women's Hospital, Melbourne, Australia has provided care for women at high risk of preterm birth, including those with a previous preterm birth, previous cervical surgery, uterine malformation or incidental finding of short cervix at routine ultrasound. The purpose of this study was to review this clinic's outcomes for the first decade. This was a retrospective cohort study of all referrals to the Preterm Labour Clinic during the period 2004-2013 inclusive. Seven hundred and fifty-six cases met the study inclusion criteria of appropriate risk factor, singleton pregnancy, surveillance undertaken and outcome data available. The preterm birth rate (<37 weeks) was 21.4%. The rate of preterm birth by year decreased significantly when adjusted for risk (P = 0.002). A short cervix was diagnosed in 32% of the sample, and positively correlated with lower gestational age at delivery. Fetal fibronectin and serum alkaline phosphatase were independent predictors of preterm birth <34 weeks and <37 weeks. The adjusted preterm birth rate at the Royal Women's Hospital's Preterm Labour Clinic has decreased significantly over the decade studied. Positive fetal fibronectin at 26 weeks and elevated serum alkaline phosphatase are independent predictors of preterm birth. © 2017 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

Enhanced clinical pharmacy service targeting tools: risk-predictive algorithms.

PubMed

El Hajji, Feras W D; Scullin, Claire; Scott, Michael G; McElnay, James C

2015-04-01

This study aimed to determine the value of using a mix of clinical pharmacy data and routine hospital admission spell data in the development of predictive algorithms. Exploration of risk factors in hospitalized patients, together with the targeting strategies devised, will enable the prioritization of clinical pharmacy services to optimize patient outcomes. Predictive algorithms were developed using a number of detailed steps using a 75% sample of integrated medicines management (IMM) patients, and validated using the remaining 25%. IMM patients receive targeted clinical pharmacy input throughout their hospital stay. The algorithms were applied to the validation sample, and predicted risk probability was generated for each patient from the coefficients. Risk threshold for the algorithms were determined by identifying the cut-off points of risk scores at which the algorithm would have the highest discriminative performance. Clinical pharmacy staffing levels were obtained from the pharmacy department staffing database. Numbers of previous emergency admissions and admission medicines together with age-adjusted co-morbidity and diuretic receipt formed a 12-month post-discharge and/or readmission risk algorithm. Age-adjusted co-morbidity proved to be the best index to predict mortality. Increased numbers of clinical pharmacy staff at ward level was correlated with a reduction in risk-adjusted mortality index (RAMI). Algorithms created were valid in predicting risk of in-hospital and post-discharge mortality and risk of hospital readmission 3, 6 and 12 months post-discharge. The provision of ward-based clinical pharmacy services is a key component to reducing RAMI and enabling the full benefits of pharmacy input to patient care to be realized. © 2014 John Wiley & Sons, Ltd.

Local Risk Factors in Genital Human Papilloma Virus Infection in Cervical Smears

PubMed Central

Ojiyi, EC; Dike, IE; Okeudo, C; Ejikem, C; Nzewuihe, AC; Agbata, A

2013-01-01

Background: Infection with human papilloma virus (HPV) is the main cause of cervical cancer, but the local risk factors have not been sufficiently assessed. Aim: The study is aimed at determining the prevalence and to evaluate the local risk factors of HPV infection in cervical smears at the Imo State University Teaching Hospital, Orlu, Nigeria. Subjects and Methods: The participants involved 445 randomly selected sexually active women attending the antenatal, postnatal, gynecology and family planning clinics in the Department of Obstetrics and Gynecology of the university between April 2004 and May 2012. A questionnaire assessing various socio-demographic characteristics of the participants was administered. The pap smears of the participants were examined microscopically for evidence of HPV infection. The SPSS version 17.0 (Chicago, Illinois, USA) was used to compute and analyze the results. The results were presented in tables as simple percentages. Tests of significance using the Chi-square and fisher exact tests were applied where appropriate. Results: The prevalence rate of HPV was 10.3%. The peak age-specific prevalence of 11.7% occurred in the 15-19 years age group. There were significant associations between the occurrence of HPV and multiple sexual partners, coital frequency, multiparity, contraceptive use, marital status, low socio-economic status, abnormal vaginal discharge, irregular menstruation, post-coital and post-menopausal bleeding, (P < 0.05). Conclusion: All sexually active women including teenagers should be screened for cervical HPV infection in an organized systematic program equipped with a good call and recall system. There is, therefore, a need to move emphasis from the current practice of opportunistic screening to a systematic screening of the whole population at risk despite cost implications. PMID:24380003

Primary treatments for clinically localized prostate cancer: a comprehensive lifetime cost-utility analysis

PubMed Central

Cooperberg, Matthew R.; Ramakrishna, Naren R.; Duff, Steven B.; Hughes, Kathleen E.; Sadownik, Sara; Smith, Joseph A.; Tewari, Ashutosh K.

2012-01-01

Objectives To characterize the costs and outcomes associated with radical prostatectomy (open, laparoscopic, or robot-assisted) and radiation therapy (dose-escalated 3-dimensional conformal radiation, intensity-modulated radiation, brachytherapy, or combination), using a comprehensive, lifetime decision analytic model. Patients and Methods A Markov model was constructed to follow hypothetical men with low-, intermediate-, and high-risk prostate cancer over their lifetimes following primary treatment; probabilities of outcomes were based on an exhaustive literature search yielding 232 unique publications. Patients could experience remission, recurrence, salvage treatment, metastasis, death from prostate cancer, and death from other causes. Utilities for each health state were determined, and disutilities were applied for complications and toxicities of treatment. Costs were determined from the U.S. payer perspective, with incorporation of patient costs in a sensitivity analysis. Results Differences in quality-adjusted life years across modalities were modest, ranging from 10.3 to 11.3 for low-risk patients, 9.6 to 10.5 for intermediate-risk patients, and 7.8 to 9.3 for high-risk patients. There were no statistically significant differences among surgical modalities, which tended to be more effective than radiation modalities, with the exception of combination external beam + brachytherapy for high-risk disease. Radiation modalities were consistently more expensive than surgical modalities; costs ranged from $19,901 (robot-assisted prostatectomy for low-risk disease) to $50,276 (combination radiation for high-risk disease). These findings were robust to an extensive set of sensitivity analyses. Conclusions Our analysis found small differences in outcomes and substantial differences in payer and patient costs across treatment alternatives. These findings may inform future policy discussions regarding strategies to improve efficiency of treatment selection for

Coping strategies and self-esteem in the high-risk offspring of bipolar parents.

PubMed

Goodday, Sarah M; Bentall, Richard; Jones, Steven; Weir, Arielle; Duffy, Anne

2018-03-01

This study investigated whether there were differences in coping strategies and self-esteem between offspring of parents with bipolar disorder (high-risk) and offspring of unaffected parents (control), and whether these psychological factors predicted the onset and recurrence of mood episodes. High-risk and control offspring were followed longitudinally as part of the Flourish Canadian high-risk bipolar offspring cohort study. Offspring were clinically assessed annually by a psychiatrist using semi-structured interviews and completed a measure of coping strategies and self-esteem. In high-risk offspring, avoidant coping strategies significantly increased the hazard of a new onset Diagnostic and Statistical Manual of Mental Disorders, 4th Edition twice revised mood episode or recurrence (hazard ratio: 1.89, p = 0.04), while higher self-esteem significantly decreased this hazard (hazard ratio: 2.50, p < 0.01). Self-esteem and avoidant coping significantly interacted with one another ( p < 0.05), where the risk of a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition twice revised new onset mood episode or recurrence was only significantly increased among high-risk offspring with both high avoidant coping and low self-esteem. A reduction of avoidant coping strategies in response to stress and improvement of self-esteem may be useful intervention targets for preventing the new onset or recurrence of a clinically significant mood disorder among individuals at high familial risk.

Biopsychosocial influence on shoulder pain: risk subgroups translated across preclinical and clinical prospective cohorts

PubMed Central

George, Steven Z.; Wallace, Margaret R.; Wu, Samuel S.; Moser, Michael W.; Wright, Thomas W.; Farmer, Kevin W.; Borsa, Paul A.; Parr, Jeffrey J.; Greenfield, Warren H.; Dai, Yunfeng; Li, Hua; Fillingim, Roger B.

2016-01-01

Tailored treatment based on individual risk factors is an area with promise to improve options for pain relief. Musculoskeletal pain has a biopsychosocial nature, and multiple factors should be considered when determining risk for chronic pain. This study investigated whether subgroups comprised genetic and psychological factors predicted outcomes in preclinical and clinical models of shoulder pain. Classification and regression tree analysis was performed for an exercise-induced shoulder injury cohort (n = 190) to identify high-risk subgroups, and a surgical pain cohort (n = 150) was used for risk validation. Questionnaires for fear of pain and pain catastrophizing were administered before injury and preoperatively. DNA collected from saliva was genotyped for a priori selected genes involved with pain modulation (COMT and AVPR1A) and inflammation (IL1B and TNF/LTA). Recovery was operationalized as a brief pain inventory rating of 0/10 for current pain intensity and <2/10 for worst pain intensity. Follow-up for the preclinical cohort was in daily increments, whereas follow-up for the clinical cohort was at 3, 6, and 12 months postoperatively. Risk subgroups comprised the COMT high pain sensitivity variant and either pain catastrophizing or fear of pain were predictive of heightened shoulder pain responses in the preclinical model. Further analysis in the clinical model identified the COMT high pain sensitivity variant and pain catastrophizing subgroup as the better predictor. Future studies will determine whether these findings can be replicated in other anatomical regions and whether personalized medicine strategies can be developed for this risk subgroup. PMID:25599310

Clinical Risk Assessment in Intensive Care Unit

PubMed Central

Asefzadeh, Saeed; Yarmohammadian, Mohammad H.; Nikpey, Ahmad; Atighechian, Golrokh

2013-01-01

Background: Clinical risk management focuses on improving the quality and safety of health care services by identifying the circumstances and opportunities that put patients at risk of harm and acting to prevent or control those risks. The goal of this study is to identify and assess the failure modes in the ICU of Qazvin's Social Security Hospital (Razi Hospital) through Failure Mode and Effect Analysis (FMEA). Methods: This was a qualitative-quantitative research by Focus Discussion Group (FDG) performed in Qazvin Province, Iran during 2011. The study population included all individuals and owners who are familiar with the process in ICU. Sampling method was purposeful and the FDG group members were selected by the researcher. The research instrument was standard worksheet that has been used by several researchers. Data was analyzed by FMEA technique. Results: Forty eight clinical errors and failure modes identified, results showed that the highest risk probability number (RPN) was in respiratory care “Ventilator's alarm malfunction (no alarm)” with the score 288, and the lowest was in gastrointestinal “not washing the NG-Tube” with the score 8. Conclusions: Many of the identified errors can be prevented by group members. Clinical risk assessment and management is the key to delivery of effective health care. PMID:23930171

Effect of family history on outcomes in patients treated with definitive brachytherapy for clinically localized prostate cancer.

PubMed

Peters, Christopher A; Stock, Richard G; Blacksburg, Seth R; Stone, Nelson N

2009-01-01

To determine the impact familial prostate cancer has on prognosis in men treated with brachytherapy for clinically localized prostate cancer. A total of 1,738 consecutive patients with prostate cancer (cT1-3, N0/X, M0) received low-dose-rate brachytherapy alone or in combination with external beam radiation therapy or hormone ablation from 1992 to 2005. The primary end-point was freedom from biochemical failure (FFBF) using the Phoenix definition. Minimum follow-up was 2 years and the median follow-up was 60 months (range, 24-197 months). A total of 187 of 1,738 men (11%) had a family history of prostate cancer in a first-degree relative. For the low-risk patients, both groups had similar actuarial 5-year FFBF (97.2% vs. 95.5%, p = 0.516). For intermediate-risk patients, there was a trend toward improved biochemical control in men positive for family history (5-yr FFBF 100% vs. 93.6%, p = 0.076). For the high-risk patients, men with a positive family history had similar 5-year FFBF (92.8% vs. 85.2%, p = 0.124). On multivariate analysis, family history was not significant; use of hormones, high biologic effective dose, initial prostate-specific antigen value, and Gleason score were the significant variables predicting biochemical control. This is the first study to examine the relationship of familial prostate cancer and outcomed in men treated with brachytherapy alone or in combination therapy. Men with a positive family history have clinicopathologic characteristics and biochemical outcomes similar to those with sporadic disease.

Developing performance indicators for clinical governance in dimensions of risk management and clinical effectiveness.

PubMed

Azami-Aghdash, Saber; Tabrizi, Jafar Sadegh; Sadeghi-Bazargani, Homayoun; Hajebrahimi, Sakineh; Naghavi-Behzad, Mohammad

2015-04-01

This study has been designed and conducted to develop domestic indicators for evaluating the performance of clinical governance in dimensions of risk management and clinical effectiveness. This study implemented a 5-stage process including conducting a comprehensive literature review, expert panel (∼ 1000 h per person per session, 11 experts), semi-structured interviews, a 2-round Delphi study (33 experts were in attendance) and a final expert panel (8 experts were in attendance). East Azerbaijan-Iran Province. Fifty-six specialists and experts in different fields of medical sciences. Importance and applicability of indicators. Using a thorough literature review, 361 indicators (129 risk management indicators in 4 dimensions and 232 clinical effectiveness indicators in 18 dimensions) were found. After conducting expert panels and interviews, the number of indicators decreased to 168 cases (65 risk management indicators in 4 dimensions and 103 clinical effectiveness indicators in 12 dimensions). Two rounds of Delphi identified four indicators that were omitted. The members of the final expert panel agreed on 113 indicators (43 risk management indicators in 4 dimensions and 70 clinical effectiveness indicators in 11 dimensions). In this study, indicators for assessing clinical governance in domains of risk management and clinical effectiveness were designed that can be used by policy-makers and other authorities for improving the quality of services and evaluating the performance of clinical governance. Those indicators can be used with slight modifications in other countries having healthcare systems similar to that of Iran. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Wireless local area network security.

PubMed

Bergeron, Bryan P

2004-01-01

Wireless local area networks (WLANs) are increasingly popular in clinical settings because they facilitate the use of wireless PDAs, laptops, and other pervasive computing devices at the point of care. However, because of the relative immaturity of wireless network technology and evolving standards, WLANs, if improperly configured, can present significant security risks. Understanding the security limitations of the technology and available fixes can help minimize the risks of clinical data loss and maintain compliance with HIPAA guidelines.

Clinical and treatment-related risk factors for nosocomial colonisation with extensively drug-resistant Pseudomonas aeruginosa in a haematological patient population: a matched case control study.

PubMed

Willmann, Matthias; Klimek, Anna M; Vogel, Wichard; Liese, Jan; Marschal, Matthias; Autenrieth, Ingo B; Peter, Silke; Buhl, Michael

2014-12-10

This study aimed to investigate risk factors for colonisation with extensively drug-resistant P. aeruginosa (XDR-PA) in immunocompromised patients and to build a clinical risk score (CRS) based on these results. We conducted a matched case-control study with 31 cases and 93 controls (1:3). Cases were colonised with XDR-PA during hospitalisation. Independent risk factors were determined using a three step conditional logistic regression procedure. A CRS was built with respect to the corresponding risk fraction of each risk factor, and its discriminatory power was estimated by receiver operating characteristic (ROC) analysis. The presence of a central venous catheter (OR 7.41, P = 0.0008), the presence of a urinary catheter (OR 21.04, P < 0.0001), CRP > 10 mg/dl (OR 7.36, P = 0.0015), and ciprofloxacin administration (OR 5.53, P = 0.025) were independent risk factors. The CRS exhibited a high discriminatory power, defining a high risk population with an approximately fourteen times greater risk for XDR-PA colonisation. Unnecessary use of antibiotics, particularly ciprofloxacin should be avoided, and a high standard of infection control measures must be achieved when using medical devices. A CRS can be used for adaptation of the active screening culture policy to the local setting.

Preoperative 3-Tesla Multiparametric Endorectal Magnetic Resonance Imaging Findings and the Odds of Upgrading and Upstaging at Radical Prostatectomy in Men With Clinically Localized Prostate Cancer

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hegde, John V.; Department of Radiology, Brigham and Women's Hospital, Boston, Massachusetts; Chen, Ming-Hui

Purpose: To investigate whether 3-T esla (3T) multiparametric endorectal MRI (erMRI) can add information to established predictors regarding occult extraprostatic or high-grade prostate cancer (PC) in men with clinically localized PC. Methods and Materials: At a single academic medical center, this retrospective study's cohort included 118 men with clinically localized PC who underwent 3T multiparametric erMRI followed by radical prostatectomy, from 2008 to 2011. Multivariable logistic regression analyses in all men and in 100 with favorable-risk PC addressed whether erMRI evidence of T3 disease was associated with prostatectomy T3 or Gleason score (GS) 8-10 (in patients with biopsy GS {<=}7)more » PC, adjusting for age, prostate-specific antigen level, clinical T category, biopsy GS, and percent positive biopsies. Results: The accuracy of erMRI prediction of extracapsular extension and seminal vesicle invasion was 75% and 95%, respectively. For all men, erMRI evidence of a T3 lesion versus T2 was associated with an increased odds of having pT3 disease (adjusted odds ratio [AOR] 4.81, 95% confidence interval [CI] 1.36-16.98, P=.015) and pGS 8-10 (AOR 5.56, 95% CI 1.10-28.18, P=.038). In the favorable-risk population, these results were AOR 4.14 (95% CI 1.03-16.56), P=.045 and AOR 7.71 (95% CI 1.36-43.62), P=.021, respectively. Conclusions: Three-Tesla multiparametric erMRI in men with favorable-risk PC provides information beyond that contained in known preoperative predictors about the presence of occult extraprostatic and/or high-grade PC. If validated in additional studies, this information can be used to counsel men planning to undergo radical prostatectomy or radiation therapy about the possible need for adjuvant radiation therapy or the utility of adding hormone therapy, respectively.« less

Correlates of Correct Condom Use Among High-Risk African American Men Attending an Urban STD Clinic in the South

PubMed Central

Crosby, Richard; DiClemente, Ralph J.; Yarber, William L.

2011-01-01

The purpose of this cross-sectional study was to assess prevalence and correlates of correct condom use among high-risk African American men attending a publicly-funded sexually transmitted disease (STD) clinic. Men 18 through 29 years of age and newly diagnosed with a sexually transmitted disease were further assessed for study eligibility. Of 296 meeting eligibility criteria, 271 agreed to participate thereby yielding a participation rate of 91.5%. Correct use, assessed by an index, was reported by 38%. Correct use was associated with having sex with 3 or fewer female sex partners (AOR=3.1), being in an exclusive relationship (AOR=3.2), not indicating problems with the fit or feel of condoms (AOR=2.9), and not being drunk/high while using condoms (AOR=2.6). The correct use of condoms among young African American men newly diagnosed with an STD may be a function of situational factors. These factors could potentially be addressed in the context of clinic-based behavioral intervention programs. PMID:21297891

Proton Radiotherapy for High-Risk Pediatric Neuroblastoma: Early Outcomes and Dose Comparison

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hattangadi, Jona A.; Rombi, Barbara; Provincial Agency for Proton Therapy, Trento

2012-07-01

Purpose: To report the early outcomes for children with high-risk neuroblastoma treated with proton radiotherapy (RT) and to compare the dose distributions for intensity-modulated photon RT (IMRT), three-dimensional conformal proton RT (3D-CPT), and intensity-modulated proton RT to the postoperative tumor bed. Methods and Materials: All patients with high-risk (International Neuroblastoma Staging System Stage III or IV) neuroblastoma treated between 2005 and 2010 at our institution were included. All patients received induction chemotherapy, surgical resection of residual disease, high-dose chemotherapy with stem cell rescue, and adjuvant 3D-CPT to the primary tumor sites. The patients were followed with clinical examinations, imaging, andmore » laboratory testing every 6 months to monitor disease control and side effects. IMRT, 3D-CPT, and intensity-modulated proton RT plans were generated and compared for a representative case of adjuvant RT to the primary tumor bed followed by a boost. Results: Nine patients were treated with 3D-CPT. The median age at diagnosis was 2 years (range 10 months to 4 years), and all patients had Stage IV disease. All patients had unfavorable histologic characteristics (poorly differentiated histologic features in 8, N-Myc amplification in 6, and 1p/11q chromosomal abnormalities in 4). The median tumor size at diagnosis was 11.4 cm (range 7-16) in maximal dimension. At a median follow-up of 38 months (range 11-70), there were no local failures. Four patients developed distant failure, and, of these, two died of disease. Acute side effects included Grade 1 skin erythema in 5 patients and Grade 2 anorexia in 2 patients. Although comparable target coverage was achieved with all three modalities, proton therapy achieved substantial normal tissue sparing compared with IMRT. Intensity-modulated proton RT allowed additional sparing of the kidneys, lungs, and heart. Conclusions: Preliminary outcomes reveal excellent local control with proton

Robotic radical prostatectomy in patients with high-risk disease: a review of short-term outcomes from a high-volume center.

PubMed

Jayram, Gautam; Decastro, Guarionex J; Large, Michael C; Razmaria, Aria; Zagaja, Gregory P; Shalhav, Arieh L; Brendler, Charles B

2011-03-01

Patients with high-risk prostate cancer have historically been treated with multimodal therapy and considered poor candidates for minimally invasive surgery. We reviewed our experiences with robot-assisted radical prostatectomy (RARP) in patients with high-risk clinical features. Clinical database review identified high-risk patients undergoing RARP by two high-volume robotic surgeons. D'Amico's criteria for high-risk prostate cancer were utilized: prostate-specific antigen ≥ 20 ng/mL, clinical stage ≥ T2c, or preoperative Gleason grade ≥ 8. About 148 patients were identified in the study group. Mean age at surgery was 60.9 years, and mean body mass index was 27.9. Mean estimated blood loss was 150 cc and the transfusion rate was 2.7%. Median hospital stay was 1 day and the rate of major complications (Clavien grade ≥ 3) was 3.4%. Bilateral nerve preservation was feasible in 28.4%, and the rate of positive surgical margins was 20.9%. Final pathology demonstrated extra-capsular disease in 54.1% of patients and 12.3% had lymph node involvement. At 2 years of follow-up, 21.3% of patients had experienced biochemical recurrence or had persistent disease after treatment. Continence was 91.2% (1 pad or less) and total impotence (inability to masturbate) was 48.3%. RARP does not compromise oncologic or functional outcomes in patients with high-risk prostate cancer. Although long-term study is necessary to validate oncologic and functional outcomes, our data suggest that the presence of high-risk disease is not a contraindication to a minimally invasive approach for radical prostatectomy at experienced centers.

Localized scleroderma: clinical spectrum and therapeutic update*

PubMed Central

Careta, Mariana Figueiroa; Romiti, Ricardo

2015-01-01

Scleroderma is a rare connective tissue disease that is manifested by cutaneous sclerosis and variable systemic involvement. Two categories of scleroderma are known: systemic sclerosis, characterized by cutaneous sclerosis and visceral involvement, and localized scleroderma or morphea which classically presents benign and self-limited evolution and is confined to the skin and/or underlying tissues. Localized scleroderma is a rare disease of unknown etiology. Recent studies show that the localized form may affect internal organs and have variable morbidity. Treatment should be started very early, before complications occur due to the high morbidity of localized scleroderma. In this review, we report the most important aspects and particularities in the treatment of patients diagnosed with localized scleroderma. PMID:25672301

Localized scleroderma: clinical spectrum and therapeutic update.

PubMed

Careta, Mariana Figueiroa; Romiti, Ricardo

2015-01-01

Scleroderma is a rare connective tissue disease that is manifested by cutaneous sclerosis and variable systemic involvement. Two categories of scleroderma are known: systemic sclerosis, characterized by cutaneous sclerosis and visceral involvement, and localized scleroderma or morphea which classically presents benign and self-limited evolution and is confined to the skin and/or underlying tissues. Localized scleroderma is a rare disease of unknown etiology. Recent studies show that the localized form may affect internal organs and have variable morbidity. Treatment should be started very early, before complications occur due to the high morbidity of localized scleroderma. In this review, we report the most important aspects and particularities in the treatment of patients diagnosed with localized scleroderma.

Enhancements in healthcare information technology systems: customizing vendor-supplied clinical decision support for a high-risk patient population.

PubMed

Tiwari, Ruchi; Tsapepas, Demetra S; Powell, Jaclyn T; Martin, Spencer T

2013-01-01

Healthcare organizations continue to adopt information technologies with clinical decision support (CDS) to prevent potential medication-related adverse drug events. End-users who are unfamiliar with certain high-risk patient populations are at an increased risk of unknowingly causing medication errors. The following case describes a heart transplant recipient exposed to supra-therapeutic concentrations of tacrolimus during co-administration of ritonavir as a result of vendor supplied CDS tools that omitted an interaction alert. After review of 4692 potential tacrolimus-based DDIs between 329 different drug pairs supplied by vendor CDS, the severity of 20 DDIs were downgraded and the severity of 62 were upgraded. The need for institution-specific customization of vendor-provided CDS is paramount to ensure avoidance of medication errors. Individualized care will become more important as patient populations and institutions become more specialized. In the future, vendors providing integrated CDS tools must be proactive in developing institution-specific and easily customizable CDS tools.

Enhancements in healthcare information technology systems: customizing vendor-supplied clinical decision support for a high-risk patient population

PubMed Central

Tiwari, Ruchi; Tsapepas, Demetra S; Powell, Jaclyn T

2013-01-01

Healthcare organizations continue to adopt information technologies with clinical decision support (CDS) to prevent potential medication-related adverse drug events. End-users who are unfamiliar with certain high-risk patient populations are at an increased risk of unknowingly causing medication errors. The following case describes a heart transplant recipient exposed to supra-therapeutic concentrations of tacrolimus during co-administration of ritonavir as a result of vendor supplied CDS tools that omitted an interaction alert. After review of 4692 potential tacrolimus-based DDIs between 329 different drug pairs supplied by vendor CDS, the severity of 20 DDIs were downgraded and the severity of 62 were upgraded. The need for institution-specific customization of vendor-provided CDS is paramount to ensure avoidance of medication errors. Individualized care will become more important as patient populations and institutions become more specialized. In the future, vendors providing integrated CDS tools must be proactive in developing institution-specific and easily customizable CDS tools. PMID:22813760

Establishing a Program for Individuals at High Risk for Breast Cancer

PubMed Central

Cadiz, Fernando; Kuerer, Henry M.; Puga, Julio; Camacho, Jamile; Cunill, Eduardo; Arun, Banu

2013-01-01

Our need to create a program for individuals at high risk for breast cancer development led us to research the available data on such programs. In this paper, we summarize our findings and our thinking process as we developed our own program. Breast cancer incidence is increasing worldwide. Even though there are known risk factors for breast cancer development, approximately 60% of patients with breast cancer have no known risk factor, although this situation will probably change with further research, especially in genetics. For patients with risk factors based on personal or family history, different models are available for assessing and quantifying risk. Assignment of risk levels permits tailored screening and risk reduction strategies. Potential benefits of specialized programs for women with high breast cancer risk include more cost -effective interventions as a result of patient stratification on the basis of risk; generation of valuable data to advance science; and differentiation of breast programs from other breast cancer units, which can result in increased revenue that can be directed to further improvements in patient care. Guidelines for care of patients at high risk for breast cancer are available from various groups. However, running a high-risk breast program involves much more than applying a guideline. Each high-risk program needs to be designed by its institution with consideration of local resources and country legislation, especially related to genetic issues. Development of a successful high-risk program includes identifying strengths, weaknesses, opportunities, and threats; developing a promotion plan; choosing a risk assessment tool; defining “high risk”; and planning screening and risk reduction strategies for the specific population served by the program. The information in this article may be useful for other institutions considering creation of programs for patients with high breast cancer risk. PMID:23833688

Analysis of colonoscopic perforations at a local clinic and a tertiary hospital.

PubMed

Sagawa, Toshihiko; Kakizaki, Satoru; Iizuka, Haruhisa; Onozato, Yasuhiro; Sohara, Naondo; Okamura, Shinichi; Mori, Masatomo

2012-09-21

To define the clinical characteristics, and to assess the management of colonoscopic complications at a local clinic. A retrospective review of the medical records was performed for the patients with iatrogenic colon perforations after endoscopy at a local clinic between April 2006 and December 2010. Data obtained from a tertiary hospital in the same region were also analyzed. The underlying conditions, clinical presentations, perforation locations, treatment types (operative or conservative) and outcome data for patients at the local clinic and the tertiary hospital were compared. A total of 10  826 colonoscopies, and 2625 therapeutic procedures were performed at a local clinic and 32  148 colonoscopies, and 7787 therapeutic procedures were performed at the tertiary hospital. The clinic had no perforations during diagnostic colonoscopy and 8 (0.3%) perforations were determined to be related to therapeutic procedures. The perforation rates in each therapeutic procedure were 0.06% (1/1609) in polypectomy, 0.2% (2/885) in endoscopic mucosal resection (EMR), and 3.8% (5/131) in endoscopic submucosal dissection (ESD). Perforation rates for ESD were significantly higher than those for polypectomy or EMR (P < 0.01). All of these patients were treated conservatively. On the other hand, three (0.01%) perforation cases were observed among the 24  361 diagnostic procedures performed, and these cases were treated with surgery in a tertiary hospital. Six perforations occurred with therapeutic endoscopy (perforation rate, 0.08%; 1 per 1298 procedures). Perforation rates for specific procedure types were 0.02% (1 per 5500) for polypectomy, 0.17% (1 per 561) for EMR, 2.3% (1 per 43) for ESD in the tertiary hospital. There were no differences in the perforation rates for each therapeutic procedure between the clinic and the tertiary hospital. The incidence of iatrogenic perforation requiring surgical treatment was quite low in both the clinic and the tertiary hospital

Emotion recognition deficits as predictors of transition in individuals at clinical high risk for schizophrenia: a neurodevelopmental perspective.

PubMed

Corcoran, C M; Keilp, J G; Kayser, J; Klim, C; Butler, P D; Bruder, G E; Gur, R C; Javitt, D C

2015-10-01

Schizophrenia is characterized by profound and disabling deficits in the ability to recognize emotion in facial expression and tone of voice. Although these deficits are well documented in established schizophrenia using recently validated tasks, their predictive utility in at-risk populations has not been formally evaluated. The Penn Emotion Recognition and Discrimination tasks, and recently developed measures of auditory emotion recognition, were administered to 49 clinical high-risk subjects prospectively followed for 2 years for schizophrenia outcome, and 31 healthy controls, and a developmental cohort of 43 individuals aged 7-26 years. Deficit in emotion recognition in at-risk subjects was compared with deficit in established schizophrenia, and with normal neurocognitive growth curves from childhood to early adulthood. Deficits in emotion recognition significantly distinguished at-risk patients who transitioned to schizophrenia. By contrast, more general neurocognitive measures, such as attention vigilance or processing speed, were non-predictive. The best classification model for schizophrenia onset included both face emotion processing and negative symptoms, with accuracy of 96%, and area under the receiver-operating characteristic curve of 0.99. In a parallel developmental study, emotion recognition abilities were found to reach maturity prior to traditional age of risk for schizophrenia, suggesting they may serve as objective markers of early developmental insult. Profound deficits in emotion recognition exist in at-risk patients prior to schizophrenia onset. They may serve as an index of early developmental insult, and represent an effective target for early identification and remediation. Future studies investigating emotion recognition deficits at both mechanistic and predictive levels are strongly encouraged.

Analysis of the relationship between periodontal disease and atherosclerosis within a local clinical system: a cross-sectional observational pilot study.

PubMed

Kudo, Chieko; Shin, Wee Soo; Minabe, Masato; Harai, Kazuo; Kato, Kai; Seino, Hiroaki; Goke, Eiji; Sasaki, Nobuhiro; Fujino, Takemasa; Kuribayashi, Nobuichi; Pearce, Youko Onuki; Taira, Masato; Maeda, Hiroshi; Takashiba, Shogo

2015-09-01

It has been revealed that atherosclerosis and periodontal disease may have a common mechanism of "chronic inflammation". Several reports have indicated that periodontal infection is related to atherosclerosis, but none have yet reported such an investigation through the cooperation of local clinics. This study was performed in local Japanese clinics to examine the relationship between periodontal disease and atherosclerosis under collaborative medical and dental care. A pilot multicenter cross-sectional study was conducted on 37 medical patients with lifestyle-related diseases under consultation in participating medical clinics, and 79 periodontal patients not undergoing medical treatment but who were seen by participating dental clinics. Systemic examination and periodontal examination were performed at baseline, and the relationships between periodontal and atherosclerosis-related clinical markers were analyzed. There was a positive correlation between LDL-C level and plasma IgG antibody titer to Porphyromonas gingivalis. According to the analysis under adjusted age, at a cut-off value of 5.04 for plasma IgG titer to Porphyromonas gingivalis, the IgG titer was significantly correlated with the level of low-density lipoprotein cholesterol (LDL-C). This study suggested that infection with periodontal bacteria (Porphyromonas gingivalis) is associated with the progression of atherosclerosis. Plasma IgG titer to Porphyromonas gingivalis may be useful as the clinical risk marker for atherosclerosis related to periodontal disease. Moreover, the application of the blood examination as a medical check may lead to the development of collaborative medical and dental care within the local medical clinical system for the purpose of preventing the lifestyle-related disease.

Clinical impact of the NKp30/B7-H6 axis in high-risk neuroblastoma patients.

PubMed

Semeraro, Michaela; Rusakiewicz, Sylvie; Minard-Colin, Véronique; Delahaye, Nicolas F; Enot, David; Vély, Frédéric; Marabelle, Aurélien; Papoular, Benjamin; Piperoglou, Christelle; Ponzoni, Mirco; Perri, Patrizia; Tchirkov, Andrei; Matta, Jessica; Lapierre, Valérie; Shekarian, Tala; Valsesia-Wittmann, Sandrine; Commo, Frédéric; Prada, Nicole; Poirier-Colame, Vichnou; Bressac, Brigitte; Cotteret, Sophie; Brugieres, Laurence; Farace, Françoise; Chaput, Nathalie; Kroemer, Guido; Valteau-Couanet, Dominique; Zitvogel, Laurence

2015-04-15

The immunosurveillance mechanisms governing high-risk neuroblastoma (HR-NB), a major pediatric malignancy, have been elusive. We identify a potential role for natural killer (NK) cells, in particular the interaction between the NK receptor NKp30 and its ligand, B7-H6, in the metastatic progression and survival of HR-NB after myeloablative multimodal chemotherapy and stem cell transplantation. NB cells expressing the NKp30 ligand B7-H6 stimulated NK cells in an NKp30-dependent manner. Serum concentration of soluble B7-H6 correlated with the down-regulation of NKp30, bone marrow metastases, and chemoresistance, and soluble B7-H6 contained in the serum of HR-NB patients inhibited NK cell functions in vitro. The expression of distinct NKp30 isoforms affecting the polarization of NK cell functions correlated with 10-year event-free survival in three independent cohorts of HR-NB in remission from metastases after induction chemotherapy (n = 196, P < 0.001), adding prognostic value to known risk factors such as N-Myc amplification and age >18 months. We conclude that the interaction between NKp30 and B7-H6 may contribute to the fate of NB patients and that both the expression of NKp30 isoforms on circulating NK cells and the concentration of soluble B7-H6 in the serum may be clinically useful as biomarkers for risk stratification. Copyright © 2015, American Association for the Advancement of Science.

Learning from high risk industries may not be straightforward: a qualitative study of the hierarchy of risk controls approach in healthcare.

PubMed

Liberati, Elisa G; Peerally, Mohammad Farhad; Dixon-Woods, Mary

2018-02-01

Though healthcare is often exhorted to learn from 'high-reliability' industries, adopting tools and techniques from those sectors may not be straightforward. We sought to examine the hierarchies of risk controls approach, used in high-risk industries to rank interventions according to supposed effectiveness in reducing risk, and widely advocated as appropriate for healthcare. Classification of risk controls proposed by clinical teams following proactive detection of hazards in their clinical systems. Classification was based on a widely used hierarchy of controls developed by the US National Institute for Occupational Safety and Health (NIOSH). A range of clinical settings in four English NHS hospitals. The four clinical teams in our study planned a total of 42 risk controls aimed at addressing safety hazards. Most (n = 35) could be classed as administrative controls, thus qualifying among the weakest type of interventions according to the HoC approach. Six risk controls qualified as 'engineering' controls, i.e. the intermediate level of the hierarchy. Only risk control qualified as 'substitution', classified as the strongest type of intervention by the HoC. Many risk controls introduced by clinical teams may cluster towards the apparently weaker end of an established hierarchy of controls. Less clear is whether the HoC approach as currently formulated is useful for the specifics of healthcare. Valuable opportunities for safety improvement may be lost if inappropriate hierarchical models are used to guide the selection of patient safety improvement interventions. Though learning from other industries may be useful, caution is needed. © The Author(s) 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care.

High and low neurobehavior disinhibition clusters within locales: implications for community efforts to prevent substance use disorder.

PubMed

Ridenour, Ty A; Reynolds, Maureen; Ahlqvist, Ola; Zhai, Zu Wei; Kirisci, Levent; Vanyukov, Michael M; Tarter, Ralph E

2013-05-01

Knowledge of where substance use and other such behavioral problems frequently occur has aided policing, public health, and urban planning strategies to reduce such behaviors. Identifying locales characterized by high childhood neurobehavioral disinhibition (ND), a strong predictor of substance use and consequent disorder (SUD), may likewise improve prevention efforts. The distribution of ND in 10-12-year olds was mapped to metropolitan Pittsburgh, PA, and tested for clustering within locales. The 738 participating families represented the population in terms of economic status, race, and population distribution. ND was measured using indicators of executive cognitive function, emotion regulation, and behavior control. Innovative geospatial analyzes statistically tested clustering of ND within locales while accounting for geographic barriers (large rivers, major highways), parental SUD severity, and neighborhood quality. Clustering of youth with high and low ND occurred in specific locales. Accounting for geographic barriers better delineated where high ND is concentrated, areas which also tended to be characterized by greater parental SUD severity and poorer neighborhood quality. Offering programs that have been demonstrated to improve inhibitory control in locales where youth have high ND on average may reduce youth risk for SUD and other problem behaviors. As demonstrated by the present results, geospatial analysis of youth risk factors, frequently used in community coalition strategies, may be improved with greater statistical and measurement rigor.

High-Dose-Rate Monotherapy for Localized Prostate Cancer: 10-Year Results

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hauswald, Henrik; Kamrava, Mitchell R.; Fallon, Julia M.

2016-03-15

Purpose: High-dose-rate (HDR) brachytherapy was originally used with external beam radiation therapy (EBRT) to increase the dose to the prostate without injuring the bladder or rectum. Numerous studies have reported HDR brachytherapy is safe and effective. We adapted it for use without EBRT for cases not requiring lymph node treatment. Patients and Methods: We entered the patient demographics, disease characteristics, and treatment parameters into a prospective registry and serially added follow-up data for 448 men with low-risk (n=288) and intermediate-risk (n=160) prostate cancer treated from 1996 to 2009. Their median age was 64 years (range 42-90). The median prostate-specific antigen (PSA)more » level was 6.0 ng/mL (range 0.2-18.2). The Gleason score was ≤6 in 76% and 7 in 24%. The median dose was 43.5 Gy in 6 fractions. The clinical and biochemical disease control and survival rates were calculated. Adverse events were graded according to the Common Toxicity Criteria of Adverse Events. Results: The median follow-up period was 6.5 years (range 0.3-15.3). The actuarial 6- and 10-year PSA progression-free survival was 98.6% (95% confidence interval [CI] 96.9%-99.4%) and 97.8% (95% CI 95.5%-98.9%). Overall survival at 10 years was 76.7% (95% CI 69.9%-82.2%). The local control, distant metastasis-free survival, and cause-specific survival were 99.7% (95% CI 97.9%-99.9%), 98.9% (95% CI 96.3%-99.7%), and 99.1% (95% CI 95.8%-99.8%). T stage, initial PSA level, Gleason score, National Comprehensive Cancer Network risk group, patient age, and androgen deprivation therapy did not significantly correlate with disease control or survival. No late grade 3 to 4 rectal toxicities developed. Late grade 3 to 4 genitourinary toxicity occurred in 4.9% (grade 3 in 4.7%). Conclusions: HDR monotherapy is a safe and highly effective treatment of low- and intermediate-risk prostate cancer.« less

Outcome According to Elective Pelvic Radiation Therapy in Patients With High-Risk Localized Prostate Cancer: A Secondary Analysis of the GETUG 12 Phase 3 Randomized Trial

DOE Office of Scientific and Technical Information (OSTI.GOV)

Blanchard, Pierre, E-mail: pierre.blanchard@gustaveroussy.fr; University of Paris-Sud, Cancer Campus, Villejuif; Faivre, Laura

Purpose: The role of pelvic elective nodal irradiation (ENI) in the management of prostate cancer is controversial. This study analyzed the role of pelvic radiation therapy (RT) on the outcome in high-risk localized prostate cancer patients included in the Groupe d'Etude des Tumeurs Uro-Genitales (GETUG) 12 trial. Methods and Materials: Patients with a nonpretreated high-risk localized prostate cancer and a staging lymphadenectomy were randomly assigned to receive either goserelin every 3 months for 3 years and 4 cycles of docetaxel plus estramustine or goserelin alone. Local therapy was administered 3 months after the start of systemic treatment. Performance of pelvic ENI was leftmore » to the treating physician. Only patients treated with primary RT were included in this analysis. The primary endpoint was biochemical progression-free survival (bPFS). Results: A total of 413 patients treated from 2002 to 2006 were included, of whom 358 were treated using primary RT. A total of 208 patients received pelvic RT and 150 prostate-only RT. Prostate-specific antigen (PSA) concentration, Gleason score, or T stage did not differ according to performance of pelvic RT; pN+ patients more frequently received pelvic RT than pN0 patients (P<.0001). Median follow-up was 8.8 years. In multivariate analysis, bPFS was negatively impacted by pN stage (hazard ratio [HR]: 2.52 [95% confidence interval [CI]: 1.78-3.54], P<.0001), Gleason score 8 or higher (HR: 1.41 [95% CI: 1.03-1.93], P=.033) and PSA higher than 20 ng/mL (HR: 1.41 [95% CI: 1.02-1.96], P=.038), and positively impacted by the use of chemotherapy (HR: 0.66 [95% CI: 0.48-0.9], P=.009). There was no association between bPFS and use of pelvic ENI in multivariate analysis (HR: 1.10 [95% CI: 0.78-1.55], P=.60), even when analysis was restricted to pN0 patients (HR: 0.88 [95% CI: 0.59-1.31], P=.53). Pelvic ENI was not associated with increased acute or late patient reported toxicity. Conclusions: This unplanned analysis

Outcome According to Elective Pelvic Radiation Therapy in Patients With High-Risk Localized Prostate Cancer: A Secondary Analysis of the GETUG 12 Phase 3 Randomized Trial.

PubMed

Blanchard, Pierre; Faivre, Laura; Lesaunier, François; Salem, Naji; Mesgouez-Nebout, Nathalie; Deniau-Alexandre, Elisabeth; Rolland, Frédéric; Ferrero, Jean-Marc; Houédé, Nadine; Mourey, Loïc; Théodore, Christine; Krakowski, Ivan; Berdah, Jean-François; Baciuchka, Marjorie; Laguerre, Brigitte; Davin, Jean-Louis; Habibian, Muriel; Culine, Stéphane; Laplanche, Agnès; Fizazi, Karim

2016-01-01

The role of pelvic elective nodal irradiation (ENI) in the management of prostate cancer is controversial. This study analyzed the role of pelvic radiation therapy (RT) on the outcome in high-risk localized prostate cancer patients included in the Groupe d'Etude des Tumeurs Uro-Genitales (GETUG) 12 trial. Patients with a nonpretreated high-risk localized prostate cancer and a staging lymphadenectomy were randomly assigned to receive either goserelin every 3 months for 3 years and 4 cycles of docetaxel plus estramustine or goserelin alone. Local therapy was administered 3 months after the start of systemic treatment. Performance of pelvic ENI was left to the treating physician. Only patients treated with primary RT were included in this analysis. The primary endpoint was biochemical progression-free survival (bPFS). A total of 413 patients treated from 2002 to 2006 were included, of whom 358 were treated using primary RT. A total of 208 patients received pelvic RT and 150 prostate-only RT. Prostate-specific antigen (PSA) concentration, Gleason score, or T stage did not differ according to performance of pelvic RT; pN+ patients more frequently received pelvic RT than pN0 patients (P<.0001). Median follow-up was 8.8 years. In multivariate analysis, bPFS was negatively impacted by pN stage (hazard ratio [HR]: 2.52 [95% confidence interval [CI]: 1.78-3.54], P<.0001), Gleason score 8 or higher (HR: 1.41 [95% CI: 1.03-1.93], P=.033) and PSA higher than 20 ng/mL (HR: 1.41 [95% CI: 1.02-1.96], P=.038), and positively impacted by the use of chemotherapy (HR: 0.66 [95% CI: 0.48-0.9], P=.009). There was no association between bPFS and use of pelvic ENI in multivariate analysis (HR: 1.10 [95% CI: 0.78-1.55], P=.60), even when analysis was restricted to pN0 patients (HR: 0.88 [95% CI: 0.59-1.31], P=.53). Pelvic ENI was not associated with increased acute or late patient reported toxicity. This unplanned analysis of a randomized trial failed to demonstrate a benefit of pelvic ENI

Can dysfunctional HDL explain high coronary artery disease risk in South Asians?

PubMed

Dodani, Sunita; Kaur, Rajwinderjit; Reddy, Srinavasa; Reed, Guy L; Navab, Mohammad; George, Varghese

2008-09-16

Coronary artery disease (CAD) is the leading cause of mortality and morbidity in United States, and South Asian immigrants (SAIs) have a higher risk for CAD compare to Caucasians. Traditional risk factors do not completely explain high risk, and some of the unknown risk factors need to be explored. We assessed dysfunctional pro-inflammatory high density lipoprotein (HDL) in SAIs and assessed its association with sub-clinical CAD using carotid intima-media thickness (IMT) as a surrogate marker for atherosclerosis. Cross-sectional study on SAIs aged 40-65 years. Sub-clinical CAD was measured using carotid intima media thickness (IMT) as a surrogate marker of atherosclerosis. Dysfunctional or pro-inflammatory HDL was determined by novel cell free assay and HDL inflammatory Index. Dysfunctional HDL was found in the 50% participants, with HDL-inflammatory index of >or=1.00, suggesting pro-inflammatory HDL (95% CI, 0.8772-1.4333). The prevalence of sub-clinical CAD using carotid IMT (>or=0.80 mm) was seen in 41.4% (95% CI, 0.2347-0.5933). On logistic regression analysis, positive carotid IMT was found to be associated with dysfunctional HDL after adjusting for age, family history of cardiovascular disease, and hypertension (p=0.030). The measurement of HDL level as well as functionality plays an important role in CAD risk assessment. Those SAIs with dysfunctional HDL and without known CAD can be a high risk group requiring treatment with lipid lowering drugs to reduce future risk of CAD. Further large studies are required to explore association of dysfunctional HDL with CAD and identify additional CAD risk caused by dysfunctional HDL.

Pressure Ulcer Risk Evaluation in Critical Patients: Clinical and Social Characteristics.

PubMed

de Azevedo Macena, Mônica Suêla; da Costa Silva, Rayanne Suely; Dias Fernandes, Maria Isabel Da Conceição; de Almeida Medeiros, Ana Beatriz; Batista Lúcio, Kadyjina Daiane; de Carvalho Lira, Ana Luisa Brandão

2017-01-01

Pressure ulcers increase hospital stays and treatment costs due to their complications. Therefore, recognizing factors that contribute to pressure ulcer risk are important to patient safety. To evaluate the association between the scores of the Waterlow, Braden, and Norton scales and clinical and social characteristics in critically ill patients. A cross-sectional study of 78 patients in an adult intensive care unit of a university hospital in Northeastern Brazil was conducted from July to December 2015. Data included social and clinical information and the risk factors of the Braden, Norton and Waterlow scales. Data were analysed by the descriptive and inferential statistics. Most of the participants were female, adults and elderly people with brown skin colour, low education levels and insufficient income. Most of them showed a high risk for developing pressure ulcers using the three evaluated scales. Age, smoking status, diabetes and hypertension were associated with scores on the Waterlow, Braden and Norton scales. Age, use of the tobacco, diabetes and hypertension were associated with the risk of pressure ulcers in ICU patients.

Relation between cannabis use and subcortical volumes in people at clinical high risk of psychosis.

PubMed

Buchy, Lisa; Mathalon, Daniel H; Cannon, Tyrone D; Cadenhead, Kristin S; Cornblatt, Barbara A; McGlashan, Thomas H; Perkins, Diana O; Seidman, Larry J; Tsuang, Ming T; Walker, Elaine F; Woods, Scott W; Bearden, Carrie E; Addington, Jean

2016-08-30

Among people at genetic risk of schizophrenia, those who use cannabis show smaller thalamic and hippocampal volumes. We evaluated this relationship in people at clinical high risk (CHR) of psychosis. The Alcohol and Drug Use Scale was used to identify 132 CHR cannabis users, the majority of whom were non-dependent cannabis users, 387 CHR non-users, and 204 healthy control non-users, and all participants completed magnetic resonance imaging scans. Volumes of the thalamus, hippocampus and amygdala were extracted with FreeSurfer, and compared across groups. Comparing all CHR participants with healthy control participants revealed no significant differences in volumes of any ROI. However, when comparing CHR users to CHR non-users, a significant ROI×Cannabis group effect emerged: CHR users showed significantly smaller amygdala compared to CHR non-users. However, when limiting analysis to CHR subjects who reported using alcohol at a 'use without impairment' severity level, the amygdala effect was non-significant; rather, smaller hippocampal volumes were seen in CHR cannabis users compared to non-users. Controlling statistically for effects of alcohol and tobacco use rendered all results non-significant. These results highlight the importance of controlling for residual confounding effects of other substance use when examining the relationship between cannabis use and neural structure. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Patients who return to care after tracking remain at high risk of attrition: experience from a large HIV clinic, Uganda.

PubMed

Nakiwogga-Muwanga, A; Musaazi, J; Katabira, E; Worodria, W; Talisuna, S Alamo; Colebunders, R

2015-01-01

We determined the retention rate of patients infected with HIV who resumed care after being tracked at the Infectious Diseases Clinic (IDC) in Kampala, Uganda. Between April 2011 and September 2013, patients who missed their clinic appointment for 8-90 days were tracked, and those who returned to the clinic within 120 days were followed up. The proportion of patients retained among tracked patients, and those who resumed care before tracking started was compared. At 18 months of follow up, 33 (39%) of the tracked patients and 72 (61%) of those who had resumed care before tracking started were retained in care. The most important cause of attrition among the traceable was self-transfer to another clinic (38 [73%] patients), whereas among those who resumed care before tracking was loss to follow up (LTFU) (32 [71%] patients). Tracked patients who resume care following a missed appointment are at high risk of attrition. To increase retention, antiretroviral therapy clinics need to adopt a chronic care model which takes into consideration patients' changing needs and their preference for self-management. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Mechanisms for the Termination of Atrial Fibrillation by Localized Ablation: Computational and Clinical Studies.

PubMed

Rappel, Wouter-Jan; Zaman, Junaid A B; Narayan, Sanjiv M

2015-12-01

Human atrial fibrillation (AF) can terminate after ablating localized regions, which supports the existence of localized rotors (spiral waves) or focal drivers. However, it is unclear why ablation near a spiral wave tip would terminate AF and not anchor reentry. We addressed this question by analyzing competing mechanisms for AF termination in numeric simulations, referenced to clinical observations. Spiral wave reentry was simulated in monodomain 2-dimensional myocyte sheets using clinically realistic rate-dependent values for repolarization and conduction. Heterogeneous models were created by introduction of parameterized variations in tissue excitability. Ablation lesions were applied as nonconducting circular regions. Models confirmed that localized ablation may anchor spiral wave reentry, producing organized tachycardias. Several mechanisms referenced to clinical observations explained termination of AF to sinus rhythm. First, lesions may create an excitable gap vulnerable to invasion by fibrillatory waves. Second, ablation of rotors in regions of low-excitability (from remodeling) produced re-entry in more excitable tissue allowing collision of wavefront and back. Conversely, ablation of rotors in high-excitability regions migrated spiral waves to less excitable tissue, where they detached to collide with nonconducting boundaries. Third, ablation may connect rotors to nonconducting anatomic orifices. Fourth, reentry through slow-conducting channels may terminate if ablation closes these channels. Limited ablation can terminate AF by several mechanisms. These data shed light on how clinical AF may be sustained in patients' atria, emphasizing heterogeneities in tissue excitability, slow-conducting channels, and obstacles that are increasingly detectable in patients and should be the focus of future translational studies. © 2015 American Heart Association, Inc.

Clinical endometritis in an Argentinean herd of dairy cows: risk factors and reproductive efficiency.

PubMed

Giuliodori, M J; Magnasco, R P; Becu-Villalobos, D; Lacau-Mengido, I M; Risco, C A; de la Sota, R L

2013-01-01

The objectives of this study were to assess the clinical and metabolic risk factors for clinical endometritis, the likelihood for having a normal vaginal discharge during postpartum, and the effects of endometritis on milk yield, reproductive efficiency, and metabolic status in Holstein cows. The study was conducted in a commercial dairy herd (Cordoba, Argentina) where 303 Holstein cows were enrolled. Cows were body condition scored (1 to 5) and tail bled on -14, 7, 21, 31, 41, and 50 d relative to parturition. Cows having a vaginal discharge with presence of pus between 21 and 41 d postpartum (dpp) were diagnosed as having clinical endometritis. Plasma blood samples were analyzed for nonesterified fatty acids (NEFA), β-hydroxybutyrate (BHBA), and blood urea nitrogen using commercial kits and insulin-like growth factor 1, insulin, and leptin by RIA. Data were analyzed with PROC MIXED, PROC GENMOD, and PROC PHREG of SAS (SAS Institute Inc., Cary, NC). Abnormal calving and puerperal metritis increased the risk for endometritis [adjusted odds ratio (AOR)=2.21 for both]. High prepartum NEFA and high postpartum BHBA increased the risk for endometritis (AOR=1.003 and 1.001, respectively), whereas high prepartum blood urea nitrogen reduced it (AOR=0.853). Cut-offs of 456.6 μM NEFA and 402.5 μM BHBA had sensitivities of 0.69 and 0.58, and specificities of 0.88 and 0.86, respectively. The likelihood for having normal vaginal discharge increased with time (∼1% × dpp) and with normal calving. Cows with endometritis had higher milk yield than normal herdmates (27.8±0.9 vs. 25.7±0.4 kg/d), lower risk for pregnancy by 100 dpp (AOR=0.10), higher nonpregnancy risk by 200 dpp (AOR=2.87), and higher risk for culling than normal cows (AOR=2.28). Cows with endometritis had a lower hazard rate (0.44) for pregnancy and had approximately 70 d longer calving-to-conception intervals. Finally, endometritis had no effect on metabolic hormones. In conclusion, the risk for clinical

Alcohol consumption and risk-factors for ischemic heart disease in Chuckchi inhabitants: clinical, biological and population studies.

PubMed

Chernobrovkina, T V; Arkavy, J V; Astakhova, T I

1991-01-01

Clinical, biochemical and epidemiological research has shown variations of serum enzymatic constellations (relatively high level of GGT in Chuckchi natives compared to nonnative newcomers). This difference leads to different unspecific body resistance to exogenous factors, particularly to histamine-liberators. The GGT system has also been linked to alcohol-induced clinical IHD. Based on these findings patients will be screened for GGT activity, which may serve as a marker for population phenotypes representative of high-risk groups. This deficiency in GGT may indicate a high risk for alcohol-related heart disease.

Risk of Localized and Advanced Prostate Cancer Among Immigrants Versus Native-Born Swedish Men: A nation-wide, population-based study

PubMed Central

Loeb, Stacy; Drevin, Linda; Robinson, David; Holmberg, Erik; Carlsson, Sigrid; Lambe, Mats; Stattin, Pär

2016-01-01

Purpose Prostate cancer (PCa) incidence and prognosis vary geographically. We examined possible differences in PCa risk by clinical risk category between native-born and immigrant populations in Sweden. Our hypothesis was that lower PSA-testing uptake among foreign-born men would result in lower rates of localized disease, and similar or higher risk of metastatic disease. Methods Using the Prostate Cancer database Sweden (PCBaSe), we identified 117,328 men with PCa diagnosed from 1991–2008, of which 8,332 were foreign-born. For each case, 5 cancer-free matched controls were randomly selected from the population register. Conditional logistic regression was used to compare low-risk, intermediate-risk, high-risk, regionally metastatic, and distant metastatic PCa based upon region of origin. Results Across all risk categories, immigrants had significantly lower PCa risk than native-born Swedish men, except North Americans and Northern Europeans. The lowest PCa risk was observed in men from the Middle East, Southern Europe and Asia. Multivariable adjustment for socioeconomic factors and comorbidities did not materially change risk estimates. Older age at immigration and more recent arrival in Sweden were associated with lower PCa risk. Non-native men were less likely to be diagnosed with PCa through PSA-testing during a health check-up. Conclusions The risk for all stages of PCa was lower among first-generation immigrants to Sweden compared to native-born men. Older age at immigration and more recent immigration were associated with particularly low risks. Patterns of PSA testing appeared to only partly explain the differences in PCa risk, since immigrant men also had a lower risk of metastatic disease. PMID:23266834

A phase II study evaluating neo-/adjuvant EIA chemotherapy, surgical resection and radiotherapy in high-risk soft tissue sarcoma.

PubMed

Schmitt, Thomas; Lehner, Burkhard; Kasper, Bernd; Bischof, Marc; Roeder, Falk; Dietrich, Sascha; Dimitrakopoulou-Strauss, Antonia; Strauss, Ludwig G; Mechtersheimer, Gunhild; Wuchter, Patrick; Ho, Anthony D; Egerer, Gerlinde

2011-12-07

The role of chemotherapy in high-risk soft tissue sarcoma is controversial. Though many patients undergo initial curative resection, distant metastasis is a frequent event, resulting in 5-year overall survival rates of only 50-60%. Neo-adjuvant and adjuvant chemotherapy (CTX) has been applied to achieve pre-operative cytoreduction, assess chemosensitivity, and to eliminate occult metastasis. Here we report on the results of our non-randomized phase II study on neo-adjuvant treatment for high-risk STS. Patients with potentially curative high-risk STS (size ≥ 5 cm, deep/extracompartimental localization, tumor grades II-III [FNCLCC]) were included. The protocol comprised 4 cycles of neo-adjuvant chemotherapy (EIA, etoposide 125 mg/m(2) iv days 1 and 4, ifosfamide 1500 mg/m2 iv days 1 - 4, doxorubicin 50 mg/m(2) day 1, pegfilgrastim 6 mg sc day 5), definitive surgery with intra-operative radiotherapy, adjuvant radiotherapy and 4 adjuvant cycles of EIA. Between 06/2005 and 03/2010 a total of 50 subjects (male = 33, female = 17, median age 50.1 years) were enrolled. Median follow-up was 30.5 months. The majority of primary tumors were located in the extremities or trunk (92%), 6% originated in the abdomen/retroperitoneum. Response by RECIST criteria to neo-adjuvant CTX was 6% CR (n = 3), 24% PR (n = 12), 62% SD (n = 31) and 8% PD (n = 4). Local recurrence occurred in 3 subjects (6%). Distant metastasis was observed in 12 patients (24%). Overall survival (OS) and disease-free survival (DFS) at 2 years was 83% and 68%, respectively. Multivariate analysis failed to prove influence of resection status or grade of histological necrosis on OS or DFS. Severe toxicities included neutropenic fever (4/50), cardiac toxicity (2/50), and CNS toxicity (4/50) leading to CTX dose reductions in 4 subjects. No cases of secondary leukemias were observed so far. The current protocol is feasible for achieving local control rates, as well as OS and DFS comparable to previously published

Specificity of Incident Diagnostic Outcomes in Patients at Clinical High Risk for Psychosis

PubMed Central

Webb, Jadon R; Addington, Jean; Perkins, Diana O; Bearden, Carrie E; Cadenhead, Kristin S; Cannon, Tyrone D; Cornblatt, Barbara A; Heinssen, Robert K; Seidman, Larry J; Tarbox, Sarah I; Tsuang, Ming; Walker, Elaine; McGlashan, Thomas H; Woods, Scott W

2015-01-01

Abstract It is not well established whether the incident outcomes of the clinical high-risk (CHR) syndrome for psychosis are diagnostically specific for psychosis or whether CHR patients also are at elevated risk for a variety of nonpsychotic disorders. We collected 2 samples (NAPLS-1, PREDICT) that contained CHR patients and a control group who responded to CHR recruitment efforts but did not meet CHR criteria on interview (help-seeking comparison patients [HSC]). Incident diagnostic outcomes were defined as the occurrence of a SIPS-defined psychosis or a structured interview diagnosis from 1 of 3 nonpsychotic Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) groups (anxiety, bipolar, or nonbipolar mood disorder), when no diagnosis in that group was present at baseline. Logistic regression revealed that the CHR vs HSC effect did not vary significantly across study for any emergent diagnostic outcome; data from the 2 studies were therefore combined. CHR (n = 271) vs HSC (n = 171) emergent outcomes were: psychosis 19.6% vs 1.8%, bipolar disorders 1.1% vs 1.2%, nonbipolar mood disorders 4.4% vs 5.3%, and anxiety disorders 5.2% vs 5.3%. The main effect of CHR vs HSC was statistically significant (OR = 13.8, 95% CI 4.2–45.0, df = 1, P < .001) for emergent psychosis but not for any emergent nonpsychotic disorder. Sensitivity analyses confirmed these findings. Within the CHR group emergent psychosis was significantly more likely than each nonpsychotic DSM-IV emergent disorder, and within the HSC group emergent psychosis was significantly less likely than most emergent nonpsychotic disorders. The CHR syndrome is specific as a marker for research on predictors and mechanisms of developing psychosis. PMID:26272875

Clinical management of patients with hypertension and high cardiovascular risk in specialised centers and in general practice. Analysis from an Italian Survey Questionnaire.

PubMed

Tocci, G; Palano, F; Battistoni, A; Citoni, B; Musumeci, M B; Ferrucci, A; Borghi, C; Volpe, M

2015-09-01

Hypertension control remains poorly achieved worldwide, despite the use of modern diagnostic tools and advanced therapeutic strategies. We aimed to evaluate the preferences expressed by either specialised physicians (SPs) or general practitioners (GPs) for the clinical management of hypertension and high cardiovascular risk in Italy. A predefined questionnaire was anonymously administered to a large community sample of physicians, stratified according to clinical expertise. From a total of 64 questions, 557 physicians (478 male, mean age 54.2 ± 7.1 years, average age of medical activity 28.0 ± 8.1 years), including 261 (46.9%) SPs and 296 (53.1%) GPs, provided 9564 answers to the survey questionnaire. Involved clinicians spent the majority of their time and practice for hypertension management and control. SPs aimed to achieve the recommended BP targets (<140/90 mmHg), whereas GPs tended to achieve more rigorous BP goals (<130/80 mmHg); nonetheless, they both reported a very high rate of BP control (about 70%). Concomitant presence of diabetes, organ damage, as well as comorbidities, was reported to be relatively frequent (26-50%), mostly by SPs. ESH/ESC 2007 risk score stratification was preferred by SPs compared to GPs, who favored a comprehensive clinical evaluation. ACE inhibitors or ARBs were considered the best pharmacological option to start antihypertensive treatment, thus adding diuretics or calcium-channel blockers, if needed. This predefined analysis of a survey questionnaire showed relatively different opinions with respect to recommended BP targets and distributions of cardiovascular risk profile, and similar diagnostic and therapeutic choices between GPs and SPs. Copyright © 2015 Elsevier B.V. All rights reserved.

Prediction of transition from ultra-high risk to first-episode psychosis using a probabilistic model combining history, clinical assessment and fatty-acid biomarkers.

PubMed

Clark, S R; Baune, B T; Schubert, K O; Lavoie, S; Smesny, S; Rice, S M; Schäfer, M R; Benninger, F; Feucht, M; Klier, C M; McGorry, P D; Amminger, G P

2016-09-20

Current criteria identifying patients with ultra-high risk of psychosis (UHR) have low specificity, and less than one-third of UHR cases experience transition to psychosis within 3 years of initial assessment. We explored whether a Bayesian probabilistic multimodal model, combining baseline historical and clinical risk factors with biomarkers (oxidative stress, cell membrane fatty acids, resting quantitative electroencephalography (qEEG)), could improve this specificity. We analyzed data of a UHR cohort (n=40) with a 1-year transition rate of 28%. Positive and negative likelihood ratios were calculated for predictor variables with statistically significant receiver operating characteristic curves (ROCs), which excluded oxidative stress markers and qEEG parameters as significant predictors of transition. We clustered significant variables into historical (history of drug use), clinical (Positive and Negative Symptoms Scale positive, negative and general scores and Global Assessment of Function) and biomarker (total omega-3, nervonic acid) groups, and calculated the post-test probability of transition for each group and for group combinations using the odds ratio form of Bayes' rule. Combination of the three variable groups vastly improved the specificity of prediction (area under ROC=0.919, sensitivity=72.73%, specificity=96.43%). In this sample, our model identified over 70% of UHR patients who transitioned within 1 year, compared with 28% identified by standard UHR criteria. The model classified 77% of cases as very high or low risk (P>0.9, <0.1) based on history and clinical assessment, suggesting that a staged approach could be most efficient, reserving fatty-acid markers for 23% of cases remaining at intermediate probability following bedside interview.

Cow-specific risk factors for clinical mastitis in Brazilian dairy cattle.

PubMed

Oliveira, C S F; Hogeveen, H; Botelho, A M; Maia, P V; Coelho, S G; Haddad, J P A

2015-10-01

Information related to mastitis risk factors is useful for the design and implementation of clinical mastitis (CM) control programs. The first objective of our study was to model the risk of CM under Brazilian conditions, using cow-specific risk factors. Our second objective was to explore which risk factors were associated with the occurrence of the most common pathogens involved in Brazilian CM infections. The analyses were based on 65 months of data from 9,789 dairy cows and 12,464 CM cases. Cow-specific risk factors that could easily be measured in standard Brazilian dairy farms were used in the statistical analyses, which included logistic regression and multinomial logistic regression. The first month of lactation, high somatic cell count, rainy season and history of clinical mastitis cases were factors associated with CM for both primiparous and multiparous cows. In addition, parity and breed were also associated risk factors for multiparous cows. Of all CM cases, 54% showed positive bacteriological culturing results from which 57% were classified as environmental pathogens, with a large percentage of coliforms (35%). Coagulase-negative Staphylococcus (16%), Streptococcus uberis (9%), Streptococcus agalactiae (7%) and other Streptococci (9%) were also common pathogens. Among the pathogens analyzed, the association of cow-specific risk factors, such as Zebu breed (OR=5.84, 95%CI 3.77-10.77) and accumulated history of SCC (1.76, 95%CI 1.37-2.27), was different for CM caused by Coagulase-negative Staphylococcus and S. agalactiae in comparison to CM caused by coliforms. Our results suggest that CM control programs in Brazil should specially consider the recent history of clinical mastitis cases and the beginning of the lactations, mainly during the rainy season as important risk factor for mastitis. Copyright © 2015 Elsevier B.V. All rights reserved.

High-Risk Stress Fractures: Diagnosis and Management.

PubMed

McInnis, Kelly C; Ramey, Lindsay N

2016-03-01

Stress fractures are common overuse injuries in athletes. They occur during periods of increased training without adequate rest, disrupting normal bone reparative mechanisms. There are a host of intrinsic and extrinsic factors, including biochemical and biomechanical, that put athletes at risk. In most stress fractures, the diagnosis is primarily clinical, with imaging indicated at times, and management focused on symptom-free relative rest with advancement of activity as tolerated. Overall, stress fractures in athletes have an excellent prognosis for return to sport, with little risk of complication. There is a subset of injuries that have a greater risk of fracture progression, delayed healing, and nonunion and are generally more challenging to treat with nonoperative care. Specific locations of high-risk stress fracture include the femoral neck (tension side), patella, anterior tibia, medial malleolus, talus, tarsal navicular, proximal fifth metatarsal, and great toe sesamoids. These sites share a characteristic region of high tensile load and low blood flow. High-risk stress fractures require a more aggressive approach to evaluation, with imaging often necessary, to confirm early and accurate diagnosis and initiate immediate treatment. Treatment consists of nonweight-bearing immobilization, often with a prolonged period away from sport, and a more methodic and careful reintroduction to athletic activity. These stress fractures may require surgical intervention. A high index of suspicion is essential to avoid delayed diagnosis and optimize outcomes in this subset of stress fractures. Copyright © 2016 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

A biomarker-based risk score to predict death in patients with atrial fibrillation: the ABC (age, biomarkers, clinical history) death risk score

PubMed Central

Hijazi, Ziad; Oldgren, Jonas; Lindbäck, Johan; Alexander, John H; Connolly, Stuart J; Eikelboom, John W; Ezekowitz, Michael D; Held, Claes; Hylek, Elaine M; Lopes, Renato D; Yusuf, Salim; Granger, Christopher B; Siegbahn, Agneta; Wallentin, Lars

2018-01-01

Abstract Aims In atrial fibrillation (AF), mortality remains high despite effective anticoagulation. A model predicting the risk of death in these patients is currently not available. We developed and validated a risk score for death in anticoagulated patients with AF including both clinical information and biomarkers. Methods and results The new risk score was developed and internally validated in 14 611 patients with AF randomized to apixaban vs. warfarin for a median of 1.9 years. External validation was performed in 8548 patients with AF randomized to dabigatran vs. warfarin for 2.0 years. Biomarker samples were obtained at study entry. Variables significantly contributing to the prediction of all-cause mortality were assessed by Cox-regression. Each variable obtained a weight proportional to the model coefficients. There were 1047 all-cause deaths in the derivation and 594 in the validation cohort. The most important predictors of death were N-terminal pro B-type natriuretic peptide, troponin-T, growth differentiation factor-15, age, and heart failure, and these were included in the ABC (Age, Biomarkers, Clinical history)-death risk score. The score was well-calibrated and yielded higher c-indices than a model based on all clinical variables in both the derivation (0.74 vs. 0.68) and validation cohorts (0.74 vs. 0.67). The reduction in mortality with apixaban was most pronounced in patients with a high ABC-death score. Conclusion A new biomarker-based score for predicting risk of death in anticoagulated AF patients was developed, internally and externally validated, and well-calibrated in two large cohorts. The ABC-death risk score performed well and may contribute to overall risk assessment in AF. ClinicalTrials.gov identifier NCT00412984 and NCT00262600 PMID:29069359

Family history of psychosis as a predictor or protective factor of social maladjustment in a population at clinical high risk for psychosis

PubMed Central

Poe, S. Lucy; Gill, Kelly E.; Brucato, Gary; Corcoran, Cheryl M.; Girgis, Ragy R.

2018-01-01

Literature suggests that social maladjustment is predictive of psychosis. We assessed 70 clinical high risk (CHR) patients for social maladjustment. There were no significant differences between patients with a positive or negative family history, suggesting that the relationship between social maladjustment and psychosis found in the recent literature may not translate to a relationship between social maladjustment and family history of psychosis in a CHR population. PMID:25063019

Neurocognitive dysfunction in subjects at clinical high risk for psychosis: A meta-analysis.

PubMed

Zheng, Wei; Zhang, Qing-E; Cai, Dong-Bin; Ng, Chee H; Ungvari, Gabor S; Ning, Yu-Ping; Xiang, Yu-Tao

2018-05-05

Findings of neurocognitive dysfunction in subjects at Clinical High Risk for Psychosis (CHR-P) have been controversial. This meta-analysis systematically examined studies of neurocognitive functions using the MATRICS Consensus Cognitive Battery (MCCB) in CHR-P. An independent literature search of both English and Chinese databases was conducted by two reviewers. Standardized mean difference (SMD) was calculated using a random effects model to evaluate the effect size of the meta-analytic results. Six case-control studies (n = 396) comparing neurocognitive functions between CHR-P subjects (n = 197) and healthy controls (n = 199) using the MCCB were identified; 4 (66.7%) studies were rated as "high quality". Compared to healthy controls, CHR-P subjects showed impairment with large effect size in overall cognition (n = 128, SMD = -1.00, 95%CI: -1.38, -0.63, P < 0.00001; I 2  = 2%), processing speed (SMD = -1.21) and attention/vigilance (SMD = -0.83), and with medium effect size in working memory (SMD = -0.76), reasoning and problem solving (SMD = -0.71), visual (SMD = -0.68) and verbal learning (SMD = -0.67). No significant difference between CHR-P subjects and controls was found regarding social cognition (SMD = -0.33, 95%CI: -0.76, 0.10, P = 0.14; I 2  = 70%) with small effect size. Apart from social cognition, CHR-P subjects performed worse than healthy control in all MCCB cognitive domains, particularly in processing speed, attention/vigilance and working memory. Copyright © 2018 Elsevier Ltd. All rights reserved.

Clinical Risk Stratification for Primary Prevention Implantable Cardioverter Defibrillators

PubMed Central

Hardy, Judy; Yee, Raymond; Healey, Jeffrey S.; Birnie, David; Simpson, Christopher S.; Crystal, Eugene; Mangat, Iqwal; Nanthakumar, Kumaraswamy; Wang, Xuesong; Krahn, Andrew D.; Dorian, Paul; Austin, Peter C.; Tu, Jack V.

2015-01-01

Background— A conceptualized model may be useful for understanding risk stratification of primary prevention implantable cardioverter defibrillators considering the competing risks of appropriate implantable cardioverter defibrillator shock versus mortality. Methods and Results— In a prospective, multicenter, population-based cohort with left ventricular ejection fraction ≤35% referred for primary prevention implantable cardioverter defibrillator, we developed dual risk stratification models to determine the competing risks of appropriate defibrillator shock versus mortality using a Fine-Gray subdistribution hazard model. Among 7020 patients referred, 3445 underwent defibrillator implant (79.7% men, median, 66 years [25th, 75th: 58–73]). During 5918 person-years of follow-up, appropriate shock occurred in 204 patients (3.6 shocks/100 person-years) and 292 died (4.9 deaths/100 person-years). Competing risk predictors of appropriate shock included nonsustained ventricular tachycardia, atrial fibrillation, serum creatinine concentration, digoxin or amiodarone use, and QRS duration near 130-ms peak. One-year cumulative incidence of appropriate shock was 0.9% in the lowest risk category, and 1.7%, 2.5%, 4.9%, and 9.3% in low, intermediate, high, and highest risk groups, respectively. Hazard ratios for appropriate shock ranged from 4.04 to 7.79 in the highest 3 deciles (all P≤0.001 versus lowest risk). Cumulative incidence of 1-year death was 0.6%, 1.9%, 3.3%, 6.2%, and 17.7% in lowest, low, intermediate, high, and highest risk groups, respectively. Mortality hazard ratios ranged from 11.48 to 36.22 in the highest 3 deciles (all P<0.001 versus lowest risk). Conclusions— Simultaneous estimation of risks of appropriate shock and mortality can be performed using clinical variables, providing a potential framework for identification of patients who are unlikely to benefit from prophylactic implantable cardioverter defibrillator. PMID:26224792

Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial.

PubMed

Hernández, Gonzalo; Vaquero, Concepción; Colinas, Laura; Cuena, Rafael; González, Paloma; Canabal, Alfonso; Sanchez, Susana; Rodriguez, Maria Luisa; Villasclaras, Ana; Fernández, Rafael

2016-10-18

High-flow conditioned oxygen therapy delivered through nasal cannulae and noninvasive mechanical ventilation (NIV) may reduce the need for reintubation. Among the advantages of high-flow oxygen therapy are comfort, availability, lower costs, and additional physiopathological mechanisms. To test if high-flow conditioned oxygen therapy is noninferior to NIV for preventing postextubation respiratory failure and reintubation in patients at high risk of reintubation. Multicenter randomized clinical trial in 3 intensive care units in Spain (September 2012-October 2014) including critically ill patients ready for planned extubation with at least 1 of the following high-risk factors for reintubation: older than 65 years; Acute Physiology and Chronic Health Evaluation II score higher than 12 points on extubation day; body mass index higher than 30; inadequate secretions management; difficult or prolonged weaning; more than 1 comorbidity; heart failure as primary indication for mechanical ventilation; moderate to severe chronic obstructive pulmonary disease; airway patency problems; or prolonged mechanical ventilation. Patients were randomized to undergo either high-flow conditioned oxygen therapy or NIV for 24 hours after extubation. Primary outcomes were reintubation and postextubation respiratory failure within 72 hours. Noninferiority margin was 10 percentage points. Secondary outcomes included respiratory infection, sepsis, and multiple organ failure, length of stay and mortality; adverse events; and time to reintubation. Of 604 patients (mean age, 65 [SD, 16] years; 388 [64%] men), 314 received NIV and 290 high-flow oxygen. Sixty-six patients (22.8%) in the high-flow group vs 60 (19.1%) in the NIV group were reintubation (absolute difference, -3.7%; 95% CI, -9.1% to ∞); 78 patients (26.9%) in the high-flow group vs 125 (39.8%) in the NIV group experienced postextubation respiratory failure (risk difference, 12.9%; 95% CI, 6.6% to ∞) [corrected]. Median time to

Outcome of High-Risk Myelodysplastic Syndrome After Azacitidine Treatment Failure

PubMed Central

Prébet, Thomas; Gore, Steven D.; Esterni, Benjamin; Gardin, Claude; Itzykson, Raphael; Thepot, Sylvain; Dreyfus, François; Rauzy, Odile Beyne; Recher, Christian; Adès, Lionel; Quesnel, Bruno; Beach, C.L.; Fenaux, Pierre; Vey, Norbert

2011-01-01

Purpose Azacitidine (AZA) is the current standard of care for high-risk (ie, International Prognostic Scoring System high or intermediate 2) myelodysplastic syndrome (MDS), but most patients will experience primary or secondary treatment failure. The outcome of these patients has not yet been described. Patients and Methods Overall, 435 patients with high-risk MDS and former refractory anemia with excess blasts in transformation (RAEB-T) were evaluated for outcome after AZA failure. The cohort of patients included four data sets (ie, AZA001, J9950, and J0443 trials and the French compassionate use program). Results The median follow-up after AZA failure was 15 months. The median overall survival was 5.6 months, and the 2-year survival probability was 15%. Increasing age, male sex, high-risk cytogenetics, higher bone marrow blast count, and the absence of prior hematologic response to AZA were associated with significantly worse survival in multivariate analysis. Data on treatment administered after AZA failure were available for 270 patients. Allogeneic stem-cell transplantation and investigational agents were associated with a better outcome when compared with conventional clinical care. Conclusion Outcome after AZA failure is poor. Our results should serve as a basis for designing second-line clinical trials in this population. PMID:21788559

'Mechanical restraint-confounders, risk, alliance score': testing the clinical validity of a new risk assessment instrument.

PubMed

Deichmann Nielsen, Lea; Bech, Per; Hounsgaard, Lise; Alkier Gildberg, Frederik

2017-08-01

Unstructured risk assessment, as well as confounders (underlying reasons for the patient's risk behaviour and alliance), risk behaviour, and parameters of alliance, have been identified as factors that prolong the duration of mechanical restraint among forensic mental health inpatients. To clinically validate a new, structured short-term risk assessment instrument called the Mechanical Restraint-Confounders, Risk, Alliance Score (MR-CRAS), with the intended purpose of supporting the clinicians' observation and assessment of the patient's readiness to be released from mechanical restraint. The content and layout of MR-CRAS and its user manual were evaluated using face validation by forensic mental health clinicians, content validation by an expert panel, and pilot testing within two, closed forensic mental health inpatient units. The three sub-scales (Confounders, Risk, and a parameter of Alliance) showed excellent content validity. The clinical validations also showed that MR-CRAS was perceived and experienced as a comprehensible, relevant, comprehensive, and useable risk assessment instrument. MR-CRAS contains 18 clinically valid items, and the instrument can be used to support the clinical decision-making regarding the possibility of releasing the patient from mechanical restraint. The present three studies have clinically validated a short MR-CRAS scale that is currently being psychometrically tested in a larger study.

Prostate cancer-specific mortality after radical prostatectomy or external beam radiation therapy in men with 1 or more high-risk factors.

PubMed

D'Amico, Anthony V; Chen, Ming-Hui; Catalona, William J; Sun, Leon; Roehl, Kimberly A; Moul, Judd W

2007-07-01

Estimates of prostate cancer-specific mortality (PCSM) were determined after radical prostatectomy (RP) or radiation therapy (RT) in men with >or=1 high-risk factors. The study cohort comprised 948 men who underwent RP (N = 660) or RT (N = 288) for localized prostate cancer between 1988 and 2004 and had at least 1 of the following high-risk factors: a prostate-specific antigen (PSA) velocity >2 ng/mL/year during the year before diagnosis, a biopsy Gleason score of >or=7, a PSA level of >or=10 ng/mL, or clinical category T2b or high disease. Grays regression was used to evaluate whether the number and type of high-risk factors were associated with time to PCSM. Multiple determinants of high risk were found to be significantly associated with a shorter time to PCSM after RP (P < .001) or RT (P 2 ng/mL/year was associated with an increased risk of PCSM after RP (hazards ratio [HR] of 7.3; 95% confidence interval [95% CI], 1.0-59 [P = .05]) or RT (HR of 12.1; 95% CI, 1.4-105 [P = .02]) when compared with men with any other single high-risk factor. Men with a PSA velocity >2 ng/mL/year had a significantly higher risk of PCSM compared with men who had any other single high-risk factor. These men should be considered for randomized trials evaluating the impact on PCSM from adding systemic agents to standards of care for men with high-risk PC. Copyright (c) 2007 American Cancer Society.

Patient preference for counselling predicts postpartum depression: a prospective 1-year follow up study in high-risk women.

PubMed

Verkerk, Gerda J M; Denollet, Johan; Van Heck, Guus L; Van Son, Maarten J M; Pop, Victor J M

2004-11-15

Patient preferences have been associated with a positive effect of depression treatment. Little is known about patient preferences in at-risk samples. The aim of this study was to examine the role of patient preference for counselling in the occurrence of postpartum depression in high-risk women. We conducted a prospective 1-year follow up study in two hospitals and four midwifery practices in The Netherlands. Participants were 90 pregnant women at high risk for postpartum depression: 45 high-risk women who preferred no counselling, 45 high-risk women who preferred counselling. Both groups received care as usual. The main outcome measure was clinical depression (Research Diagnostic Criteria) at 3, 6, and 12 months postpartum. Point-prevalence rates of clinical depression were significantly higher in high-risk women who preferred counselling compared with high-risk women who did not prefer counselling (24% versus 9%, P=0.048; 19% versus 5%, P=0.048, at 3 and 6 months postpartum, respectively). No significant difference was found at 12 months postpartum. Across the first-year postpartum, high-risk women who preferred counselling were at seven-fold increased risk for clinical depression (OR=7.7, 95% CI 1.7-33.8, P=0.007). Patient preference for counselling is an important predictor of postpartum depression in pregnant women at high risk for postpartum depression. Patient preferences may reflect validly a perceived need for intervention in high-risk women. This finding emphasises the need to take patient preference for counselling into account as an important variable to identify a high-risk population.

Clinical update on thrombolytic use in pulmonary embolism: A focus on intermediate-risk patients.

PubMed

Eberle, Hannah; Lyn, Raquel; Knight, Tamara; Hodge, Emily; Daley, Mitchell

2018-06-12

Current literature on clinical controversies surrounding the use of thrombolytic agents in patients with intermediate-risk pulmonary embolism (PE) is reviewed. PE is a major cause of morbidity and mortality. When used in conjunction with anticoagulation, thrombolysis has been shown to reduce hemodynamic decompensation in select patients, but thrombolytic therapy is associated with high risks of bleeding and intracranial hemorrhage and its role in treating patients with intermediate-risk PE remains controversial. In the PEITHO study, the largest trial to date involving only patients with intermediate-risk PE ( n = 1,006), patients receiving the thrombolytic agent tenecteplase were significantly ( p = 0.02) less likely than those receiving unfractionated heparin to develop the primary outcome, a composite of death from any cause and hemodynamic decompensation or collapse within 7 days. However, a meta-analysis of data from clinical trials of systemic thrombolytic therapy in intermediate-risk PE generally showed a lack of benefit in terms of all-cause mortality and long-term complications. Novel strategies for treatment of intermediate-risk PE, including low-dose thrombolysis and catheter-directed thrombolysis, are being investigated in an attempt to identify strategies that provide therapeutic outcomes equivalent to those provided by traditional thrombolytic modalities but with a decreased risk of bleeding. The use of thrombolysis in the treatment of intermediate-risk PE is complicated by high rates of bleeding and should be limited to patients who clinically deteriorate rather than given as a standard-of-care treatment in this population. Data for low-dose thrombolysis remain limited. Copyright © 2018 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Randomized clinical trials in dentistry: Risks of bias, risks of random errors, reporting quality, and methodologic quality over the years 1955-2013.

PubMed

Saltaji, Humam; Armijo-Olivo, Susan; Cummings, Greta G; Amin, Maryam; Flores-Mir, Carlos

2017-01-01

To examine the risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions and the development of these aspects over time. We included 540 randomized clinical trials from 64 selected systematic reviews. We extracted, in duplicate, details from each of the selected randomized clinical trials with respect to publication and trial characteristics, reporting and methodologic characteristics, and Cochrane risk of bias domains. We analyzed data using logistic regression and Chi-square statistics. Sequence generation was assessed to be inadequate (at unclear or high risk of bias) in 68% (n = 367) of the trials, while allocation concealment was inadequate in the majority of trials (n = 464; 85.9%). Blinding of participants and blinding of the outcome assessment were judged to be inadequate in 28.5% (n = 154) and 40.5% (n = 219) of the trials, respectively. A sample size calculation before the initiation of the study was not performed/reported in 79.1% (n = 427) of the trials, while the sample size was assessed as adequate in only 17.6% (n = 95) of the trials. Two thirds of the trials were not described as double blinded (n = 358; 66.3%), while the method of blinding was appropriate in 53% (n = 286) of the trials. We identified a significant decrease over time (1955-2013) in the proportion of trials assessed as having inadequately addressed methodological quality items (P < 0.05) in 30 out of the 40 quality criteria, or as being inadequate (at high or unclear risk of bias) in five domains of the Cochrane risk of bias tool: sequence generation, allocation concealment, incomplete outcome data, other sources of bias, and overall risk of bias. The risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions have improved over time; however, further efforts that contribute to the development of more stringent

Association of Tissue Abiraterone Levels and SLCO Genotype with Intraprostatic Steroids and Pathologic Response in Men with High-Risk Localized Prostate Cancer.

PubMed

Mostaghel, Elahe A; Cho, Eunpi; Zhang, Ailin; Alyamani, Mohammad; Kaipainen, Arja; Green, Sean; Marck, Brett T; Sharifi, Nima; Wright, Jonathan L; Gulati, Roman; True, Lawrence D; Loda, Massimo; Matsumoto, Alvin M; Tamae, Daniel; Penning, Trevor N; Balk, Steven P; Kantoff, Phillip W; Nelson, Peter S; Taplin, Mary-Ellen; Montgomery, R Bruce

2017-08-15

Purpose: Germline variation in solute carrier organic anion ( SLCO ) genes influences cellular steroid uptake and is associated with prostate cancer outcomes. We hypothesized that, due to its steroidal structure, the CYP17A inhibitor abiraterone may undergo transport by SLCO -encoded transporters and that SLCO gene variation may influence intracellular abiraterone levels and outcomes. Experimental Design: Steroid and abiraterone levels were measured in serum and tissue from 58 men with localized prostate cancer in a clinical trial of LHRH agonist plus abiraterone acetate plus prednisone for 24 weeks prior to prostatectomy. Germline DNA was genotyped for 13 SNPs in six SLCO genes. Results: Abiraterone levels spanned a broad range (serum median 28 ng/mL, 108 nmol/L; tissue median 77 ng/mL, 271 nmol/L) and were correlated ( r = 0.355, P = 0.001). Levels correlated positively with steroids upstream of CYP17A (pregnenolone, progesterone), and inversely with steroids downstream of CYP17A (DHEA, AED, testosterone). Serum PSA and tumor volumes were higher in men with undetectable versus detectable tissue abiraterone at prostatectomy (median 0.10 vs. 0.03 ng/dL, P = 0.02; 1.28 vs. 0.44 cc, P = 0.09, respectively). SNPs in SLCO2B1 associated with significant differences in tissue abiraterone (rs1789693, P = 0.0008; rs12422149, P = 0.03) and higher rates of minimal residual disease (tumor volume < 0.5 cc; rs1789693, 67% vs. 27%, P = 0.009; rs1077858, 46% vs. 0%, P = 0.03). LNCaP cells expressing SLCO2B1 showed two- to fourfold higher abiraterone levels compared with vector controls ( P < 0.05). Conclusions: Intraprostatic abiraterone levels and genetic variation in SLCO genes are associated with pathologic responses in high-risk localized prostate cancer. Variation in SLCO genes may serve as predictors of response to abiraterone treatment. Clin Cancer Res; 23(16); 4592-601. ©2017 AACR . ©2017 American Association for Cancer Research.

Change IS Possible: Reducing High-Risk Drinking Using a Collaborative Improvement Model.

PubMed

Lanter, Patricia L; Wolff, Kristina B; Johnson, Lisa C; Ercolano, Ellyn M; Kilmer, Jason R; Provost, Lloyd

2015-01-01

To describe the adoption of public health and improvement methodologies to address college students' high-risk drinking behaviors and to aid in prevention efforts. Members of 32 colleges and universities, content experts, and staff members of the National College Health Improvement Program (NCHIP). A 2-year learning collaborative developed by NCHIP trained individuals from 32 different college and universities in using the Plan-Do-Study-Act cycle as a method to create and implement initiatives aimed at reducing students' high-risk drinking behaviors and related harms. Participants experienced success ranging from noteworthy increases in type and amount of interventions directed at reducing high-risk drinking, to creating collaboratives across campus, the local community, and stakeholders. Challenges related to data collection and creating lasting cultural change remain. The use of quality improvement methodologies and creation of a national collaborative successfully effected meaningful change in high-risk drinking behaviors on college campuses.

Economic value of atopic dermatitis prevention via infant formula use in high-risk Malaysian infants.

PubMed

Bhanegaonkar, Abhijeet J; Horodniceanu, Erica G; Abdul Latiff, Amir Hamzah; Woodhull, Sanjay; Khoo, Phaik Choo; Detzel, Patrick; Ji, Xiang; Botteman, Marc F

2015-04-01

Breastfeeding is best for infants and the World Health Organization recommends exclusive breastfeeding for at least the first 6 months of life. For those who are unable to be breastfed, previous studies demonstrate that feeding high-risk infants with hydrolyzed formulas instead of cow's milk formula (CMF) may decrease the risk of atopic dermatitis (AD). To estimate the economic impact of feeding high-risk, not exclusively breastfed, urban Malaysian infants with partiallyhydrolyzed whey-based formula (PHF-W) instead of CMF for the first 17 weeks of life as an AD risk reduction strategy. A cohort Markov model simulated the AD incidence and burden from birth to age 6 years in the target population fed with PHF-W vs. CMF. The model integrated published clinical and epidemiologic data, local cost data, and expert opinion. Modeled outcomes included AD-risk reduction, time spent post AD diagnosis, days without AD flare, quality-adjusted life years (QALYs), and costs (direct and indirect). Outcomes were discounted at 3% per year. Costs are expressed in Malaysian Ringgit (MYR; MYR 1,000 = United States dollar [US $]316.50). Feeding a high-risk infant PHF-W vs. CMF resulted in a 14% point reduction in AD risk (95% confidence interval [CI], 3%-23%), a 0.69-year (95% CI, 0.25-1.10) reduction in time spent post-AD diagnosis, additional 38 (95% CI, 2-94) days without AD flare, and an undiscounted gain of 0.041 (95% CI, 0.007-0.103) QALYs. The discounted AD-related 6-year cost estimates when feeding a high-risk infant with PHF-W were MYR 1,758 (US $556) (95% CI, MYR 917-3,033) and with CMF MYR 2,871 (US $909) (95% CI, MYR 1,697-4,278), resulting in a per-child net saving of MYR 1,113 (US $352) (95% CI, MYR 317-1,884) favoring PHF-W. Using PHF-W instead of CMF in this population is expected to result in AD-related costs savings.

Economic value of atopic dermatitis prevention via infant formula use in high-risk Malaysian infants

PubMed Central

Bhanegaonkar, Abhijeet J; Horodniceanu, Erica G; Abdul Latiff, Amir Hamzah; Woodhull, Sanjay; Khoo, Phaik Choo; Detzel, Patrick; Ji, Xiang

2015-01-01

Background Breastfeeding is best for infants and the World Health Organization recommends exclusive breastfeeding for at least the first 6 months of life. For those who are unable to be breastfed, previous studies demonstrate that feeding high-risk infants with hydrolyzed formulas instead of cow's milk formula (CMF) may decrease the risk of atopic dermatitis (AD). Objective To estimate the economic impact of feeding high-risk, not exclusively breastfed, urban Malaysian infants with partiallyhydrolyzed whey-based formula (PHF-W) instead of CMF for the first 17 weeks of life as an AD risk reduction strategy. Methods A cohort Markov model simulated the AD incidence and burden from birth to age 6 years in the target population fed with PHF-W vs. CMF. The model integrated published clinical and epidemiologic data, local cost data, and expert opinion. Modeled outcomes included AD-risk reduction, time spent post AD diagnosis, days without AD flare, quality-adjusted life years (QALYs), and costs (direct and indirect). Outcomes were discounted at 3% per year. Costs are expressed in Malaysian Ringgit (MYR; MYR 1,000 = United States dollar [US $]316.50). Results Feeding a high-risk infant PHF-W vs. CMF resulted in a 14% point reduction in AD risk (95% confidence interval [CI], 3%-23%), a 0.69-year (95% CI, 0.25-1.10) reduction in time spent post-AD diagnosis, additional 38 (95% CI, 2-94) days without AD flare, and an undiscounted gain of 0.041 (95% CI, 0.007-0.103) QALYs. The discounted AD-related 6-year cost estimates when feeding a high-risk infant with PHF-W were MYR 1,758 (US $556) (95% CI, MYR 917-3,033) and with CMF MYR 2,871 (US $909) (95% CI, MYR 1,697-4,278), resulting in a per-child net saving of MYR 1,113 (US $352) (95% CI, MYR 317-1,884) favoring PHF-W. Conclusion Using PHF-W instead of CMF in this population is expected to result in AD-related costs savings. PMID:25938073

Evaluating complications of local anesthesia administration and reversal with phentolamine mesylate in a portable pediatric dental clinic.

PubMed

Boynes, Sean G; Riley, Amah E; Milbee, Sarah; Bastin, Meghan R; Price, Maylyn E; Ladson, Andrea

2013-08-01

This study sought to identify and quantify complications with local anesthetic administration and reversal on consecutive patients seen for comprehensive dental care in a school-based, portable dental clinic, and includes data on the patients seen by the participating portable dental providers. In 923 dental visits where local anesthetic was administered, a standardized form was used to gain further information and identify any complications; this was accompanied by a questionnaire for the student's teacher, in order to quantify the student's distraction and disruption ratings following the dental visit. After statistical analysis of the 923 consecutive cases, the overall complication rate was 5.3%. All of the complications were considered to be mild or moderate, and there were no severe event reports. The complications encountered most frequently (n = 49) were associated with self-inflicted soft tissue injury. The results of this study indicate that comprehensive care with local anesthesia delivered by a school-based portable dental clinic has a low risk of complications. Whereas safe administration of dental care is achievable with or without phentolamine mesylate as a local anesthetic reversal agent, its use was determined to improve safety outcomes. Three factors appeared to directly increase the incidence of complications: the administration of an inferior alveolar nerve block, attention deficit disorder, and obesity. Teacher evaluations demonstrated that children receiving care by a portable dental team were able to reorient back to classwork and were not disruptive to classmates.

Exploring local risk managers' use of flood hazard maps for risk communication purposes in Baden-Württemberg

NASA Astrophysics Data System (ADS)

Kjellgren, S.

2013-07-01

In response to the EU Floods Directive (2007/60/EC), flood hazard maps are currently produced all over Europe, reflecting a wider shift in focus from "flood protection" to "risk management", for which not only public authorities but also populations at risk are seen as responsible. By providing a visual image of the foreseen consequences of flooding, flood hazard maps can enhance people's knowledge about flood risk, making them more capable of an adequate response. Current literature, however, questions the maps' awareness raising capacity, arguing that their content and design are rarely adjusted to laypeople's needs. This paper wants to complement this perspective with a focus on risk communication by studying how these tools are disseminated and marketed to the public in the first place. Judging from communication theory, simply making hazard maps publicly available is unlikely to lead to attitudinal or behavioral effects, since this typically requires two-way communication and material or symbolic incentives. Consequently, it is relevant to investigate whether and how local risk managers, who are well positioned to interact with the local population, make use of flood hazard maps for risk communication purposes. A qualitative case study of this issue in the German state of Baden-Württemberg suggests that many municipalities lack a clear strategy for using this new information tool for hazard and risk communication. Four barriers in this regard are identified: perceived disinterest/sufficient awareness on behalf of the population at risk; unwillingness to cause worry or distress; lack of skills and resources; and insufficient support. These barriers are important to address - in research as well as in practice - since it is only if flood hazard maps are used to enhance local knowledge resources that they can be expected to contribute to social capacity building.

An initial investigation of abnormal bodily phenomena in subjects at ultra high risk for psychosis: Their prevalence and clinical implications.

PubMed

Madeira, Luis; Bonoldi, Ilaria; Rocchetti, Matteo; Samson, Carly; Azis, Matilda; Queen, Beverly; Bossong, Matthijs; Perez, Jesus; Stone, James; Allen, Paul; Howes, Oliver D; McGuire, Philip; Raballo, Andrea; Fusar-Poli, Paolo; Ballerini, Massimo; Stanghellini, Giovanni

2016-04-01

Contemporary phenomenological research has considered abnormal bodily phenomena (ABP) to be a phenotypic trait of subjects with schizophrenia in their first psychotic episode. Yet the prevalence of ABP and their clinical significance in subjects at Ultra High Risk (UHR) of psychosis remain unidentified. This study is an exploratory investigation of ABP in UHR subjects and matched healthy controls (HCs) examining their relation to clinical features and basic self-disturbances. A sample of 26 UHR and 14 HC subjects from three prodromal and early intervention clinics in South London, West London and Cambridge was assessed with the Abnormal Bodily Phenomena questionnaire (ABPq), Comprehensive Assessment of At-Risk Mental States (CAARMS), the Positive and Negative Syndrome Scale (PANSS), the Social and Occupational Functioning Assessment Scale (SOFAS) and the Examination of Anomalous Self Experiences (EASE) checklist. In our sample ABP occurred in 73.1% of UHR subjects and prominent ABP (proABP) were referred in 53.8% of them. No HC subject reported ABP. The UHR group with proABP had lower CAARMS total score (t=-9.265, p=0.006). There were no differences in PANSS total score (t=-1.235, p=0.277), SOFAS score (H(2) 22.27, p=0.666) and EASE total scores (z=8.565, adjusted p=0.185) in the UHR subjects with prominent ABP versus those that did not. This initial investigation suggests that ABP could be a prevalent phenotypic feature of UHR subjects. Copyright © 2015 Elsevier Inc. All rights reserved.

Blood Glucose Levels After Local Musculoskeletal Steroid Injections in Patients With Diabetes Mellitus: A Clinical Review.

PubMed

Waterbrook, Anna L; Balcik, Brenden J; Goshinska, Aaron John

Diabetes mellitus (DM) has become an epidemic in the United States and is associated with increased risk of multiple comorbidities, including painful musculoskeletal conditions. A common treatment for many of these painful musculoskeletal conditions is local soft tissue and intra-articular corticosteroid injection (CSI). These local injections have the potential to cause elevated blood glucose levels (BGLs) and cause complications in patients with DM. Therefore, it was the objective of this investigation to review the currently available evidence that directly addresses the effects of local CSIs used for painful musculoskeletal conditions on BGL in patients with DM. PubMed, Google Scholar, EMBASE, CINAHL, and Cochrane Review databases were searched with a combination of the terms corticosteroid, glucocorticoid, steroid, injection, musculoskeletal, and diabetes. Search limits included the English language. Bibliographic references from these articles were also examined to identify pertinent literature. Clinical review. Level 3. Ten studies that met the inclusion criteria were reviewed. All these studies showed significant but transient increases in postinjection BGL after a single local CSI in patients with DM. There were no adverse reactions or complications reported. Single, local soft tissue and intra-articular musculoskeletal CSIs are most likely safe in patients with well-controlled DM.

Prospective study of cannabis use in adolescents at clinical high risk for psychosis: impact on conversion to psychosis and functional outcome.

PubMed

Auther, A M; McLaughlin, D; Carrión, R E; Nagachandran, P; Correll, C U; Cornblatt, B A

2012-12-01

Clinical and epidemiological studies suggest an association between cannabis use and psychosis but this relationship remains controversial. Clinical high-risk (CHR) subjects (age 12-22 years) with attenuated positive symptoms of psychosis (CHR+, n=101) were compared to healthy controls (HC, n=59) on rates of substance use, including cannabis. CHR+ subjects with and without lifetime cannabis use (and abuse) were compared on prodromal symptoms and social/role functioning at baseline. Participants were followed an average of 2.97 years to determine psychosis conversion status and functional outcome. At baseline, CHR+ subjects had significantly higher rates of lifetime cannabis use than HC. CHR+ lifetime cannabis users (n=35) were older (p=0.015, trend), more likely to be Caucasian (p=0.002), less socially anhedonic (p<0.001) and had higher Global Functioning: Social (GF:Social) scores (p<0.001) than non-users (n=61). CHR+ cannabis users continued to have higher social functioning than non-users at follow-up (p<0.001) but showed no differences in role functioning. A small sample of CHR+ cannabis abusers (n=10) showed similar results in that abusers were older (p=0.008), less socially anhedonic (p=0.017, trend) and had higher baseline GF:Social scores (p=0.006) than non-abusers. Logistic regression analyses revealed that conversion to psychosis in CHR+ subjects (n=15) was not related to lifetime cannabis use or abuse. The current data do not indicate that low to moderate lifetime cannabis use is a major contributor to psychosis or poor social and role functioning in clinical high-risk youth with attenuated positive symptoms of psychosis.

Automation of a DXA-based finite element tool for clinical assessment of hip fracture risk.

PubMed

Luo, Yunhua; Ahmed, Sharif; Leslie, William D

2018-03-01

Finite element analysis of medical images is a promising tool for assessing hip fracture risk. Although a number of finite element models have been developed for this purpose, none of them have been routinely used in clinic. The main reason is that the computer programs that implement the finite element models have not been completely automated, and heavy training is required before clinicians can effectively use them. By using information embedded in clinical dual energy X-ray absorptiometry (DXA), we completely automated a DXA-based finite element (FE) model that we previously developed for predicting hip fracture risk. The automated FE tool can be run as a standalone computer program with the subject's raw hip DXA image as input. The automated FE tool had greatly improved short-term precision compared with the semi-automated version. To validate the automated FE tool, a clinical cohort consisting of 100 prior hip fracture cases and 300 matched controls was obtained from a local community clinical center. Both the automated FE tool and femoral bone mineral density (BMD) were applied to discriminate the fracture cases from the controls. Femoral BMD is the gold standard reference recommended by the World Health Organization for screening osteoporosis and for assessing hip fracture risk. The accuracy was measured by the area under ROC curve (AUC) and odds ratio (OR). Compared with femoral BMD (AUC = 0.71, OR = 2.07), the automated FE tool had a considerably improved accuracy (AUC = 0.78, OR = 2.61 at the trochanter). This work made a large step toward applying our DXA-based FE model as a routine clinical tool for the assessment of hip fracture risk. Furthermore, the automated computer program can be embedded into a web-site as an internet application. Copyright © 2017 Elsevier B.V. All rights reserved.

Factors Influencing Cancer Risk Perception in High Risk Populations: A Systematic Review

PubMed Central

2011-01-01

Background Patients at higher than average risk of heritable cancer may process risk information differently than the general population. However, little is known about clinical, demographic, or psychosocial predictors that may impact risk perception in these groups. The objective of this study was to characterize factors associated with perceived risk of developing cancer in groups at high risk for cancer based on genetics or family history. Methods We searched Ovid MEDLINE, Ovid Embase, Ovid PsycInfo, and Scopus from inception through April 2009 for English-language, original investigations in humans using core concepts of "risk" and "cancer." We abstracted key information and then further restricted articles dealing with perceived risk of developing cancer due to inherited risk. Results Of 1028 titles identified, 53 articles met our criteria. Most (92%) used an observational design and focused on women (70%) with a family history of or contemplating genetic testing for breast cancer. Of the 53 studies, 36 focused on patients who had not had genetic testing for cancer risk, 17 included studies of patients who had undergone genetic testing for cancer risk. Family history of cancer, previous prophylactic tests and treatments, and younger age were associated with cancer risk perception. In addition, beliefs about the preventability and severity of cancer, personality factors such as "monitoring" personality, the ability to process numerical information, as well as distress/worry also were associated with cancer risk perception. Few studies addressed non-breast cancer or risk perception in specific demographic groups (e.g. elderly or minority groups) and few employed theory-driven analytic strategies to decipher interrelationships of factors. Conclusions Several factors influence cancer risk perception in patients at elevated risk for cancer. The science of characterizing and improving risk perception in cancer for high risk groups, although evolving, is still