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Outcome Variables (outcome + variable)
Kinds of Outcome Variables Selected AbstractsHope as an Outcome Variable Among Youths in a Residential Care SettingAMERICAN JOURNAL OF ORTHOPSYCHIATRY, Issue 3 2006Rodney McNeal PhD This study investigated changes in hope among 155 youths (ages 10 to 17 years) placed in a residential treatment facility over a 6,month period. The child and adolescent participants met criteria for a range of emotional and behavioral disorders and received interventions hypothesized to improve hopeful thinking. Hope scores significantly improved over 6 months of treatment. The positive changes in hope were not moderated by ethnicity or sex. For Agency hope scores (i.e., willpower), those with higher levels of psychopathology at admission demonstrated significantly more improvement in agency thinking over the course of 6 months. [source] Outcome Variables and Their Assessment in Alcohol Treatment Studies: 1968-1998ALCOHOLISM, Issue 10 2003John W. Finney Background: This article provides a historical overview of the assessment of outcome variables in alcohol treatment studies that were first published between 1968 and 1998. The review focuses on changes over time in (1) the number of outcome variables and the number of different types of outcome variables assessed, (2) the likelihood of assessing specific types of outcome variables, (3) the methods used to assess outcome variables, and (4) the status of outcome assessment in more recent studies first published between 1990 and 1998. Methods: Reports of 357 alcohol treatment trials with two or more treatment/control groups were coded with respect to the number and types of outcome variables assessed, sources of outcome data, and methodological aspects of outcome assessment. Results: Although the number of outcome variables assessed in studies, on average, did not increase significantly over time, the number of different types of outcome variables did increase. An expected decrease in the assessment of categorical abstinence was not found, but another categorical variable, global ratings of drinking improvement, did decrease over time. More recent studies were more likely to assess such continuous variables as time abstinent, alcohol consumption, time drinking, dependence symptoms, and drinking-related problems. Physiological markers of drinking/alcohol misuse also were assessed more frequently in later years. Some aspects of outcome assessment methods exhibited improvement over time; validity data were more likely to be provided or cited, and self-reports of drinking behaviors were more likely to be corroborated in studies first published in more recent years. However, the percentages of studies that provided/cited reliability data for outcome measures, indicated that follow-up data collectors were not affiliated with treatment and were unaware of respondents' treatment conditions, and reported that respondents were alcohol-free at follow-up did not rise significantly over time. Conclusions: Although the methods of outcome assessment improved between 1968 and 1998, much room for improvement remains. [source] Identifying Subjects Who Benefit from Additional Information for Better Prediction of the Outcome VariablesBIOMETRICS, Issue 3 2009L. Tian Summary Suppose that we are interested in using new bio- or clinical markers, in addition to the conventional markers, to improve prediction or diagnosis of the patient's clinical outcome. The incremental value from the new markers is typically assessed by averaging across patients in the entire study population. However, when measuring the new markers is costly or invasive, an overall improvement does not justify measuring the new markers in all patients. A more practical strategy is to utilize the patient's conventional markers to decide whether the new markers are needed for improving prediction of his/her health outcomes. In this article, we propose inference procedures for the incremental values of new markers across various subgroups of patients classified by the conventional markers. The resulting point and interval estimates can be quite useful for medical decision makers seeking to balance the predictive or diagnostic value of new markers against their associated cost and risk. Our proposals are theoretically justified and illustrated empirically with two real examples. [source] Helicobacter pylori first-line treatment and rescue options in patients allergic to penicillinALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 10 2005J. P. GISBERT Summary Background :,Helicobacter pylori eradication is a challenge in patients allergic to penicillin, especially those who have failed a first-eradication trial. Aim :,To assess the efficacy and tolerability of H. pylori first-line treatment and rescue options in patients allergic to penicillin. Methods :,Prospective single centre study including 40 consecutive treatments administered to patients allergic to penicillin. Therapy regimens: First-line (12 patients) omeprazole, clarithromycin and metronidazole for 7 days; second-line (17 patients) ranitidine bismuth citrate, tetracycline and metronidazole for 7 days; third-line (nine patients) rifabutin, clarithromycin and omeprazole for 10 days; and fourth-line (two patients) levofloxacin, clarithromycin and omeprazole for 10 days. Outcome variable: a negative 13C-urea breath test 8 weeks after completion of treatment. Results :,Per-protocol/intention-to-treat eradication rates were: first-line (64/58%); second-line (ranitidine bismuth citrate; 53/47%); third-line (rifabutin; 17/11%) and fourth-line regimen (levofloxacin; 100/100%). Compliance with treatment was generally good, except with the rifabutin-based regimen, which presented adverse effects in 89% of the patients, including four cases of myelotoxicity. Conclusions :,H. pylori -infected patients who are allergic to penicillin may be treated with a first-line treatment combining a proton-pump inhibitor, clarithromycin and metronidazole. Rescue options may include a regimen with ranitidine bismuth citrate, tetracycline and metronidazole. A levofloxacin-based rescue regimen (with proton-pump inhibitor and clarithromycin) may also represent an alternative, even when two or more consecutive eradication treatments have previously failed. However, rifabutin + clarithromycin + proton-pump inhibitor regimen is ineffective and poorly tolerated. [source] Determinants of continuity and change over 10 years in young women's smokingADDICTION, Issue 3 2009Liane McDermott ABSTRACT Aims To examine prospectively continuity and change in smoking behaviour and associated attributes over a 10-year period. Design, setting and participants Participants (initially aged 18,23 years) in the Australian Longitudinal Study on Women's Health completed postal questionnaires in 1996, 2000, 2003 and 2006. The analysis sample was 6840 women who participated in all surveys and provided complete smoking data. Measurements Outcome variables were transitions in smoking behaviour between surveys 1 and 2, 2 and 3, 3 and 4 and 1 and 4. Attributes that differentiated continuing smokers from quitters, relapsers from ex-smokers and adopters from never smokers were examined for each survey period. Explanatory variables included previous smoking history, demographic, psychosocial, life-style risk behaviour and life-stage transition factors. Findings Over 10 years, 23% of participants either quit, re-started, adopted or experimented with smoking. Recent illicit drug use and risky or high-risk drinking predicted continued smoking, relapse and smoking adoption. Marriage or being in a committed relationship was associated significantly with quitting, remaining an ex-smoker and not adopting smoking. Living in a rural or remote area and lower educational attainment were associated with continued smoking; moderate and high physical activity levels were associated positively with remaining an ex-smoker. Conclusions Life-style and life-stage factors are significant determinants of young women's smoking behaviour. Future research needs to examine the inter-relationships between tobacco, alcohol and illicit drug use, and to identify the determinants of continued smoking among women living in rural and remote areas. Cessation strategies could examine the role of physical activity in relapse prevention. [source] Treatment results of bisphosphonate-related osteonecrosis of the jaws,HEAD & NECK: JOURNAL FOR THE SCIENCES & SPECIALTIES OF THE HEAD AND NECK, Issue 9 2008Arno Wutzl MD Abstract Background. Osteonecrosis of the jaws occurs after the administration of bisphosphonates. An unequivocal treatment strategy is yet to be devised. We assess the treatment of patients with bisphosphonate-related osteonecrosis of the jaws (BRONJ). Methods. The investigators studied a prospective cohort of 58 patients 6 months after surgical treatment of BRONJ. Outcome variables were the status of the mucosa, the visual analog score of pain, and prosthetic rehabilitation. Preoperative staging results were compared with the postoperative outcome and statistically evaluated. Results. Of 58 patients, 41 surgically treated patients could be followed up after a mean period of 189 (±23) days. Twenty-four (58.5%) were free of pain and had an intact mucosa. A statistically significant improvement was registered between preoperative and postoperative staging (p <.01); 11 of 12 patients who had been treated with a flap procedure for soft tissue closure had an intact mucosa. Conclusions. This is the first prospective study to report the outcome of treatment in a cohort of patients with BRONJ. Minimal resection of necrotic bone and local soft tissue closure might be a feasible treatment strategy in patients with established BRONJ. © 2008 Wiley Periodicals, Inc. Head Neck 2008 [source] A longitudinal evaluation of two-year outcome in a community-based mental health service using graphical chain modelsINTERNATIONAL JOURNAL OF METHODS IN PSYCHIATRIC RESEARCH, Issue 1 2004The South-Verona Outcome Project Abstract The 2-year outcome of 178 patients attending a community-based mental health service was assessed from a multidimensional perspective. The study investigated: (1) the effect of disease-related characteristics (such as diagnosis and illness duration) and of a series of outcome variables measured at baseline (global functioning, psychopathology, social disability, quality of life and satisfaction with services) on total costs of care over 2 years; and (2) the effect of costs of care and outcome variables measured at baseline on the corresponding outcome variables at 2 years. To gain insight into the multivariate longitudinal dependencies among variables, we used graphical Gaussian chain models, a new multivariate method that analyses the relationship between continuous variables taking into account the effect of antecedent and intervening variables, to reveal not only direct but also indirect correlations. Outcome variables showed the tendency to segregate, both at baseline and follow-up, into two distinct groups: a clinician-rated dimension (given by global functioning, social disability and psychopathology) and a patient-rated dimension (given by service satisfaction and subjective quality of life). Higher costs at 2 years were predicted by higher psychopathology at baseline, diagnosis of psychosis and longer duration of illness. Baseline values for each variable were the main predictors of the corresponding values at two years. Improvement in satisfaction with life at follow-up was experienced in those subjects with a lower functioning at baseline. This study throws some light on the complex relationships between clinical, social and economic variables affecting the medium-term outcome of mental health care. Copyright © 2004 Whurr Publishers Ltd. [source] Recombinant factor VIIa and fibrinogen display additive effect during in vitro haemodilution with crystalloidsACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 3 2009C. FENGER-ERIKSEN Background: Major blood loss requires fluid resuscitation for maintaining hemodynamic stability. Excessive volume infusions predispose to dilutional coagulopathy through loss, consumption and dilution of cells and proteins involved in haemostasis. Further treatment with fibrinogen concentrate and/or recombinant activated factor VII (rFVIIa) may be initiated, although the haemostatic effects in a situation with haemodilution are not fully detailed. The present study evaluates haemostatic effect of fibrinogen and rFVIIa and their combination in an in vitro model of haemodiluted whole blood with two commonly used crystalloids. Methods: Eight healthy, male volunteers were enrolled. Outcome variables were clot initiation, propagation and strength assessed by thrombelastographic parameters: clotting time, clot formation time, maximum velocity, time until maximum velocity, maximum clot firmness evaluated at dilution levels of 0% (control), 10%, 30% and 50% with isotonic saline and Ringer's lactate in a model of tissue factor-activated whole blood. Fibrinogen and rFVIIa were additional final reaction concentrations, reflecting commonly used clinically therapeutic dosages. Results: Dose-dependent coagulopathy developed following haemodilution with isotonic saline and Ringer's lactate, characterised by a prolonged clot initiation, reduced clot propagation and reduced clot strength. Fibrinogen improved clot strength and propagation phase while rFVIIa shortened clot initiation, both with a positive dose dependency. Conclusions: The combination of fibrinogen and rFVIIa displays an additive effect and improves overall in vitro whole blood clot formation in a model of in vitro crystalloid-induced haemodilution. [source] Parental Divorce and Offspring Depressive Symptoms: Dutch Developmental Trends During Early AdolescenceJOURNAL OF MARRIAGE AND FAMILY, Issue 2 2008Albertine J. Oldehinkel In this study, we investigated if the association between parental divorce and depressive symptoms changes during early adolescence and if developmental patterns are similar for boys and girls. Data were collected in a prospective population cohort of Dutch adolescents (N = 2,149), aged 10 , 15 years. Outcome variables were self-reported and parent-reported depressive symptoms. The effects of divorce were adjusted for parental depression. In both self-reported and parent-reported data, we found a three-way interaction of gender, age, and parental divorce, indicating that with increasing age, parental divorce became more strongly associated with depressive symptoms among girls, but not boys. These results suggest that girls with divorced parents are at particularly high risk to develop depressive symptoms during adolescence. [source] In vivo inhibition of antiphospholipid antibody-induced pathogenicity utilizing the antigenic target peptide domain I of ,2 -glycoprotein I: proof of conceptJOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 5 2009Y. IOANNOU Summary.,Objectives:,In the antiphospholipid syndrome (APS), the immunodominant epitope for the majority of circulating pathogenic antiphospholipid antibodies (aPLs) is the N-terminal domain I (DI) of ,2 -glycoprotein I. We have previously shown that recombinant DI inhibits the binding of aPLs in fluid phase to immobilized native antigen, and that this inhibition is greater with the DI(D8S/D9G) mutant and absent with the DI(R39S) mutant. Hence, we hypothesized that DI and DI(D8S/D9G) would inhibit aPL-induced pathogenicity in vivo. Methods:,C57BL/6 mice (n = 5, each group) were injected with purified IgG derived from APS patients (IgG-APS, 500 ,g) or IgG from normal healthy serum (IgG-NHS) and either recombinant DI, DI(R39S), DI(D8S/D9G), or an irrelevant control peptide (at 10,40 ,g). Outcome variables measured were femoral vein thrombus dynamics in treated and control groups following standardized vessel injury, expression of vascular cell adhesion molecule-1 (VCAM-1) on the aortic endothelial surface, and tissue factor (TF) activity in murine macrophages. Results:,IgG-APS significantly increased thrombus size as compared with IgG-NHS. The IgG-APS thrombus enhancement effect was abolished in mice pretreated with recombinant DI (P , 0.0001) and DI(D8S/D9G) (P , 0.0001), but not in those treated with DI(R39S) or control peptide. This inhibitory effect by DI was dose-dependent, and at lower doses DI(D8S/D9G) was a more potent inhibitor of thrombosis than wild-type DI (P , 0.01). DI also inhibited IgG-APS induction of VCAM-1 on the aortic endothelial surface and TF production by murine macrophages. Conclusion:,Our findings in this proof-of-concept study support the development of recombinant DI or the novel variant DI(D8S/D9G) as a potential future therapeutic agent for APS. [source] Periodontal condition of the mandibular anterior dentition in patients with conventional and self-ligating bracketsORTHODONTICS & CRANIOFACIAL RESEARCH, Issue 4 2008N Pandis Structured Abstract Authors,,, Pandis N, Vlachopoulos K, Polychronopoulou A, Madianos P, Eliades T Objectives,,, To explore whether the use of self-ligating brackets is associated with better values for periodontal indices because of the lack of elastomeric modules and concomitantly, reduced availability of retentive sites for microbial colonization and plaque accumulation. Setting and Sample Population,,, Private practice of the first author. Patients were selected using the following inclusion criteria: age range 12,17 years, fixed appliances on both arches, aligned mandibular arch, and absence of oral habits and anterior crossbites. Materials and Methods,,, Prospective cohort investigation. Participants were grouped for bracket type, thus 50 patients formed the conventional bracket cohort and 50 patients the self-ligating bracket cohort. Both cohorts were followed with the purpose to examine periodontal status. Average length of follow-up was 18 months. This time period was considered adequate for a proportion of study participants to experience the outcome of interest. Outcome variables were plaque index, gingival index, calculus index, and probing depth for the two bracket cohorts. Results,,, No difference was found in the indices recorded between the two bracket cohorts studied. Conclusion,,, Under the conditions as applied in this study, the self-ligating brackets do not have an advantage over conventional brackets with respect to the periodontal status of the mandibular anterior teeth. [source] Severe upper airway obstruction in the tropics requiring intensive carePEDIATRICS INTERNATIONAL, Issue 1 2001Pwk Chan Background: The clinical profile of severe upper airway obstruction, a challenging acute pediatric emergency, has not been extensively documented in the developing nations of the tropics. Methods: The diagnostic categories, severity of illness and outcome from 63 episodes of severe upper airway obstruction in 56 children admitted to the Pediatric Intensive Care Unit between January 1994 and December 1999 were reviewed. Outcome variables studied included requirement for ventilation, mortality and complications. Severity of illness was determined with the Pediatric Risk of Mortality (PRISM) II score. Results: Viral croup (29%) was the most common diagnosis, followed by mediastinal malignancy (13%), bacterial tracheitis (11%) and Pierre Robin syndrome (11%). There were no admissions for acute epiglottitis. Thirty episodes (48%) required ventilation for a median duration of 4.0 days. Bacterial tracheitis (100%) and subglottic stenosis (100%) were the most likely diagnoses requiring ventilation. Difficulty in intubation was encountered in 13 episodes (43%) involving, in particular, patients with bacterial tracheitis (83%; P=0.006). Only two patients required a tracheostomy. The overall mortality was 11%. The PRISM score for all categories was generally low (mean 10.3~1.0; median 9.0). Non-survivors had a significantly higher PRISM II score than survivors (27.4~9.7 vs 8.1~4.9, respectively; P=0.002) and were more likely to include children with bacterial tracheitis and mediastinal malignancy. Conclusions: There is marked heterogeneity in the causes of upper airway obstruction in the tropics with viral croup remaining the most common. A significant proportion required ventilation, but outcome is generally favorable, except in those with bacterial tracheitis and mediastinal malignancy. [source] Management and outcomes of facial paralysis from intratemporal blunt trauma: A systematic review,,THE LARYNGOSCOPE, Issue 7 2010John J. Nash MD Abstract Objectives/Hypothesis: To systematically review the existing literature on outcomes and management of facial paralysis resulting from intratemporal blunt trauma. Study Design: Systematic review of the literature. Methods: Thirty-five articles met our inclusion criteria. Outcome variables analyzed included severity of paralysis, time of onset of paralysis, surgical or nonsurgical management, steroid use, and final facial nerve function. Results: All studies were classified as level 4 evidence as defined by the Oxford Centre for Evidence-Based Medicine. There was marked variation in the quality of the studies with inconsistent outcome measures, diagnostic testing, and follow-up, thus ruling out a formal meta-analysis. In an exploratory pooling of data, 612 cases had sufficient follow-up and facial movement grading for some evaluation of trends. In 189 patients who were followed observationally, 66% achieved an outcome equivalent to House-Brackmann (HB) I, 25% achieving HB II-V, and two patients an HB VI score. Among 83 patients treated with steroids, 67% achieved HB I, 30% HB II-V, and no patients with HB VI. In 340 patients treated surgically, 23% achieved HB I postoperatively, 58% were graded as HB II-V, and 9% with HB grade VI postoperatively. No patient presenting with partial paralysis had an HB VI outcome. Conclusions: The role of surgery versus nonsurgical interventions for this clinical entity remains inconclusive. Level 4 evidence studies predominate and are further hindered by poor description of outcome measures and incomplete data reporting. Exploratory pooling of data without formal meta-analysis suggests the need to compare any intervention to the natural course of healing, which overall appears to be favorable. Laryngoscope, 2010 [source] The Association Between Prehospital Endotracheal Intubation Attempts and Survival to Hospital Discharge Among Out-of-hospital Cardiac Arrest PatientsACADEMIC EMERGENCY MEDICINE, Issue 9 2010Jonathan R. Studnek PhD, NREMT-P ACADEMIC EMERGENCY MEDICINE 2010; 17:918,925 © 2010 by the Society for Academic Emergency Medicine Abstract Objectives:, The benefit of prehospital endotracheal intubation (ETI) among individuals experiencing out-of-hospital cardiac arrest (OOHCA) has not been fully examined. The objective of this study was to determine if prehospital ETI attempts were associated with return of spontaneous circulation (ROSC) and survival to discharge among individuals experiencing OOHCA. Methods:, This retrospective study included individuals who experienced a medical cardiac arrest between July 2006 and December 2008 and had resuscitation efforts initiated by paramedics from Mecklenburg County, North Carolina. Outcome variables were prehospital ROSC and survival to hospital discharge, while the primary independent variable was the number of prehospital ETI attempts. Results:, There were 1,142 cardiac arrests included in the analytic data set. Prehospital ROSC occurred in 299 individuals (26.2%). When controlling for initial arrest rhythm and other confounding variables, individuals with no ETI attempted were 2.33 (95% confidence interval [CI] = 1.63 to 3.33) times more likely to have ROSC compared to those with one successful ETI attempt. Of the 299 individuals with prehospital ROSC, 118 (39.5%) were subsequently discharged alive from the hospital. Individuals having no ETI were 5.46 (95% CI = 3.36 to 8.90) times more likely to be discharged from the hospital alive compared to individuals with one successful ETI attempt. Conclusions:, Results from these analyses suggest a negative association between prehospital ETI attempts and survival from OOHCA. In this study, the individuals most likely to have prehospital ROSC and survival to hospital discharge were those who did not have a reported ETI attempt. Further comparative research should assess the potential causes of the demonstrated associations. [source] Psycho-social issues in long-term survivors of testicular cancer: Directions for future researchASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY, Issue 3 2008Tim LUCKETT Abstract Testicular cancer is the most common non-skin cancer in young men and among the most curable of all neoplasms, making patients' long-term physical, psychological and social well-being of major concern. To date, research on outcomes has been restricted almost entirely to survivors in Europe and the USA. The current article reviews the international literature with a view to developing directions for future research in the Asia,Pacific region. We conclude that planning interventions to improve outcomes awaits further, prospective, controlled studies aimed at establishing the predictive value not only of socio-demographic, disease and treatment variables but also of psycho-social variables underlying adjustment and recovery. Ideally, research of this kind would: (i) highlight aspects of the experience of testicular cancer and its treatment that might be targeted by changes to patterns of care, and (ii) identify groups at risk of poor outcomes who could be identified for early intervention through screening. Planning of prospective research would itself benefit from further, large-scale, cross-sectional research aimed at identifying those variables that would prove most informative when tracked over time. Exploratory research of this kind should be aimed at providing a snapshot of men's well-being in the context of a comprehensive range of variables that include patterns of care, unmet needs, satisfaction with treatment and social support as well as disease and treatment variables. Outcome variables should include disease-specific concerns such as psycho-sexual problems as well as general physical, psychological and social well-being. [source] Functioning and disability in bipolar disorders: a systematic review of literature using the ICF as a referenceBIPOLAR DISORDERS, Issue 5 2010Carolina C Ávila Ávila CC, Cabello M, Cieza A, Vieta E, Ayuso-Mateos JL. Functioning and disability in bipolar disorders: a systematic review of literature using the ICF as a reference. Bipolar Disord 2010: 12: 473,482. © 2010 The Authors. Journal compilation © 2010 John Wiley & Sons A/S. Objectives:, To systematically identify and examine the frequency of use of concepts contained in outcome variables across bipolar disorder (BD) studies using the International Classification of Functioning, Disability and Health (ICF) as a reference. Methods:, Original studies published between 2000 and 2006 were located on the MEDLINE and PsycINFO databases and selected according to predetermined criteria. Outcome variables were extracted, and concepts contained therein were linked to the ICF. Results:, A total of 109 final studies were included. The concepts contained in these studies were linked to 145 different ICF categories. ICF category b152, emotional functions, was the most frequently represented category, appearing in 94% of the publications, followed by b126, temperament and personality functions (73%). E110, products or substances for personal consumption, and e580, health services, systems, and policies, appeared in 68% of the studies. Conclusions:, The present systematic review reflects the research focus of the literature on BD in recent years. Most of the studies performed concentrate on body functions rather than activities and participation domains. Experimental studies are mostly pharmacological, reflecting the need to study nonpharmacological interventions. Furthermore, our study shows that outcome variables used in studies with persons with BD can, to a large extent, be mapped to the ICF. [source] A 10-year follow-up after transurethral resection of the prostate, contact laser prostatectomy and electrovaporization in men with benign prostatic hyperplasia; long-term results of a randomized controlled trialBJU INTERNATIONAL, Issue 6 2010Robert J. Hoekstra Study Type , Therapy (RCT) Level of Evidence 1b OBJECTIVE To compare long-term results of transurethral resection of the prostate (TURP), contact laser prostatectomy (CLP) and electrovaporization of the prostate (EVAP) in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). PATIENTS AND METHODS Between 1996 and 2001, a prospective, randomized controlled trial was conducted in 150 men with LUTS suggestive of BPH, who had a prostate volume of 20,65 mL and a Schäfer's obstruction grade of ,2. Outcome variables were the International Prostate Symptom Score (IPSS), Quality of Life (QoL) question, Symptom Problem Index (SPI), BPH Impact Index (BII), maximum urinary flow rate (Qmax), prostate volume, prostate specific antigen (PSA) level, morbidity and mortality. In 2008 we carried out a long-term follow-up in these patients. Long-term values were compared with preoperative values for each treatment group (Wilcoxon signed-rank test), differences among groups were analysed (Kruskal,Wallis test) and actuarial failure-rates of the interventions were determined (Kaplan-Meier analysis). RESULTS Although we could account for 91% of the initial participants in 2008, 66 (44%) patients (29 TURP, 20 CLP and 17 EVAP) were available for follow-up measurements after a mean (range) of 10.1(6.9,12.7) years Among the three treatment groups, there were no significant differences in IPSS, QoL, SPI, BII, Qmax, PSA level and prostate volume. The IPSS, QoL, SPI and BII were still improved (P < 0.05) from values before treatment for all treatments. Only in the TURP group were the long-term results of Qmax still improved (P < 0.05). The mortality rate was comparable among the treatments. The 10-year actuarial failure rates (95% confidence interval) were 0.11 (0.03,0.20), 0.22 (0.10,0.35) and 0.23 (0.11,0.35) for TURP, CLP and EVAP, respectively. CONCLUSIONS After a mean follow-up of 10.1 years, there were similar and durable improvements in IPSS, QoL, SPI and BII for patients with LUTS suggestive of BPH after TURP, CLP and EVAP. Between the treatment groups there were no statistically significant differences in Qmax, PSA levels and prostate volume at any time during the follow-up. However, only patients treated with TURP showed minimal durable improvements in Qmax. There was no statistically significant difference in success rate and mortality rate among the three treatments. [source] HER-2/neu expression as a predictor of response to neoadjuvant docetaxel in patients with operable breast carcinomaCANCER, Issue 11 2005Peter A. Learn M.D. Abstract BACKGROUND The use of biologic markers to predict response to neoadjuvant chemotherapy may permit tailoring regimens to achieve maximal tumor response. Taxanes have demonstrated excellent activity in breast carcinoma; however, tumor-specific factors that predict clinical response have not been characterized thoroughly. METHODS The authors performed a historic review evaluating the association of tumor prognostic factors and response to neoadjuvant cyclophosphamide and doxorubicin (AC) with or without docetaxel (D) (AC vs. AC+D) in 121 women who previously were enrolled in a Phase III, randomized, clinical trial. Using pretreatment biopsy materials, immunohistochemical studies were performed for estrogen receptor (ER), progesterone receptor (PR), HER-2/neu, p53, and Ki-67. Outcome variables were pathologic complete response (pCR) and positive clinical response (cPOS), which was defined as a , 50% regression in clinical tumor size prior to surgery. RESULTS In a multivariate analysis that controlled for tumor size and lymph node status, improved cPOS rates were observed with the addition of docetaxel in women with HER-2/neu -negative tumors (81% vs. 51%; P < 0.05), yielding an adjusted odds ratio of 3.5 (95% confidence interval, 1.2,13.0) in favor of docetaxel. Women who had HER-2/neu -negative tumors appeared to have a lower response rate with AC alone compared with women who had HER-2/neu -positive tumors (51% vs. 75%; P = 0.06), but response rates were matched when docetaxel was added (81% vs. 78%; P = 0.99). ER, PR, p53, and Ki-67 results were not associated significantly with response rates. CONCLUSIONS HER-2/neu status may predict improved clinical response rates from the addition of docetaxel to anthracycline-based neoadjuvant chemotherapy. Docetaxel may "rescue" the response in women who have HER-2/neu -negative tumors to match that observed in women who have HER-2/neu -positive tumors treated with AC alone. Cancer 2005. © 2005 American Cancer Society. [source] Influence of clinical status on the association between plasma total and unbound bilirubin and death or adverse neurodevelopmental outcomes in extremely low birth weight infantsACTA PAEDIATRICA, Issue 5 2010W Oh Abstract Objectives:, To assess the influence of clinical status on the association between total plasma bilirubin and unbound bilirubin on death or adverse neurodevelopmental outcomes at 18,22 months corrected age in extremely low birth weight infants. Method:, Total plasma bilirubin and unbound bilirubin were measured in 1101 extremely low birth weight infants at 5 ± 1 days of age. Clinical criteria were used to classify infants as clinically stable or unstable. Survivors were examined at 18,22 months corrected age by certified examiners. Outcome variables were death or neurodevelopmental impairment, death or cerebral palsy, death or hearing loss, and death prior to follow-up. For all outcomes, the interaction between bilirubin variables and clinical status was assessed in logistic regression analyses adjusted for multiple risk factors. Results:, Regardless of clinical status, an increasing level of unbound bilirubin was associated with higher rates of death or neurodevelopmental impairment, death or cerebral palsy, death or hearing loss and death before follow-up. Total plasma bilirubin values were directly associated with death or neurodevelopmental impairment, death or cerebral palsy, death or hearing loss, and death before follow-up in unstable infants, but not in stable infants. An inverse association between total plasma bilirubin and death or cerebral palsy was found in stable infants. Conclusions:, In extremely low birth weight infants, clinical status at 5 days of age affects the association between total plasma bilirubin and death or adverse neurodevelopmental outcomes at 18,22 months of corrected age. An increasing level of UB is associated a higher risk of death or adverse neurodevelopmental outcomes regardless of clinical status. Increasing levels of total plasma bilirubin are directly associated with increasing risk of death or adverse neurodevelopmental outcomes in unstable, but not in stable infants. [source] Maternal hypothyroidism in early and late gestation: effects on neonatal and obstetric outcomeCLINICAL ENDOCRINOLOGY, Issue 5 2005Iskandar Idris Summary Background, Maternal hypothyroidism may be associated with a variety of adverse neonatal and obstetric outcomes. Whether these outcomes are affected by maternal thyroid status at initial presentation or in late gestation specifically within a dedicated antenatal endocrine clinic remains unclear. The effects of thyroxine dose requirement during pregnancy and serum concentrations of TSH within such clinic settings are still not known. Objectives, We investigated these outcomes in patients with hypothyroidism during early and late gestation. TSH levels and thyroxine dose requirement during early and late gestation were also evaluated. Methods, We performed a retrospective study of data from 167 pregnancies managed in the antenatal endocrine clinic. Analysis of outcomes was linked to TSH at first presentation and in the third trimester. Outcome variables included: rate of caesarean section, pre-eclampsia, neonatal unit admission, neonatal weight and gestational age. Controlled TSH was defined as mothers with TSH between 0·1 and 2 with normal free thyroid hormone levels. Results, The caesarean section (CS) rates were higher in the study cohort (H) compared with the local (C) rate (H = 28·7%, C = 18%). The higher rate in our patient cohort was not due to a higher rate of emergency section nor to a lower threshold for performing elective caesarean section. The infant birthweight (IBW) from mothers with TSH > 5·5 (H1) and mothers with TSH between 0·1 and 5·5 at presentation (H2) was [median (range)] 3·38 (1·73,4·70) vs. 3·45 (1·36,4·76); P = ns. The prevalence of low-birthweight (LBW) infants (< 2·5 g) in groups H1 and H2 was 15% and 4·8%, respectively [odds ratio (OR) = 3·55, 95% confidence interval (95% CI) = 0·96,10·31]. IBW from mothers with TSH > 2 (H3) and mothers with controlled TSH in the third trimester (H4) were similar [3·38 (1·78,4·4) vs. 3·46 (1·36,4·76); P = ns]. The prevalence of LBW in groups H3 and H4 was 9% and 4·9%, respectively (OR = 1·95, 95% CI = 0·52,7·26). The median thyroxine dose (µg) increased significantly during pregnancy (first trimester: 100; second trimester: 125, P < 0·001; and third trimester: 150, P < 0·001) associated with appropriate suppression of TSH levels in the second and third trimesters. Rates of pre-eclampsia or admissions to neonatal units were negligible. Conclusion, Thyroxine dose requirement increases during pregnancy and thus close monitoring of thyroid function with appropriate adjustment of thyroxine dose to maintain a normal serum TSH level is necessary throughout gestation. Within a joint endocrine,obstetric clinic, maternal hypothyroidism at presentation and in the third trimester may increase the risk of low birthweight and the likelihood for caesarean section. The latter observation was not due to a higher rate of emergency caesarean section nor to a lower threshold for performing elective caesarean section. A larger study with adjustments made for the various confounders is required to confirm this observation. [source] Does personality change and, if so, what changes?,CRIMINAL BEHAVIOUR AND MENTAL HEALTH, Issue 1 2004Conor Duggan Background Although the question of whether or not personality changes is fundamental to much of what clinicians do, we do not appear to be very curious about the question itself. Method This paper considers three separate but related issues: (a) Does personality change? (b) If it does, then what changes? (c) How can we show that change has taken place? Costa and McCrea have produced a model of personality that helps to answer (a) and (b), as it distinguishes ,Basic Tendencies' from ,Characteristic Adaptations'. The former are largely innate, fixed dispositions that produce the latter (which are highly variable) depending on its interaction with differing environments. Thus, personality is both static and dynamic depending on its definition. It will also be argued that detecting change is complex as there are many alternative definitions of the relevant outcome variable. Moreover, measuring several different outcomes does not help as change in one measure is often not matched by a concordant change in another. Some practical examples are provided to support this position. Conclusions In the absence of a firm theoretical base, the author believes that only limited conclusions can be drawn about the efficacy of treatment in personality disorder. Copyright © 2004 Whurr Publishers Ltd. [source] A controlled randomized treatment study: the effects of a cognitive remediation program on adolescents with early onset psychosisACTA PSYCHIATRICA SCANDINAVICA, Issue 1 2004T. Ueland Objective: To examine if a cognitive remediation program could be a positive supplement to a psychoeducational treatment program for adolescents with early onset psychosis. Method: Twenty-six subjects, randomly assigned to cognitive remediation (n = 14) or control group (n = 12), were assessed on cognitive, clinical, psychosocial and behavioural measures. Results: No significant between-group differences in pre- and post-treatment scores were found. This may be due to low statistical power. Exploratory within-group analyses showed that the training group improved on five of the 10 cognitive, and three of the five functioning outcome measures, while the control group improved on three of the cognitive, and one functioning outcome variable. Conclusion: Based on these results we cannot conclude that the addition of this cognitive remediation program, yields better results than psychoeducation alone. However, within-group analyses indicate that on specific cognitive functions, as well as on some functioning outcome measures, the remediation program may have a positive effect. [source] Exposure to cannabis in popular music and cannabis use among adolescentsADDICTION, Issue 3 2010Brian A. Primack ABSTRACT Background Cannabis use is referenced frequently in American popular music, yet it remains uncertain whether exposure to these references is associated with actual cannabis use. We aimed to determine if exposure to cannabis in popular music is associated independently with current cannabis use in a cohort of urban adolescents. Methods We surveyed all 9th grade students at three large US urban high schools. We estimated participants' exposure to lyrics referent to cannabis with overall music exposure and content analyses of their favorite artists' songs. Outcomes included current (past 30 days) and ever use of cannabis. We used multivariable regression to assess independent associations between exposures and outcomes while controlling for important covariates. Results Each of the 959 participants was exposed to an estimated 27 cannabis references per day [correction added on 19 January 2010, after first online publication: 40 has been changed to 27] (standard deviation = 73 [correction added on 19 January 2010, after first online publication: 104 has been changed to 73]). Twelve per cent (n = 108) were current cannabis users and 32% (n = 286) had ever used cannabis. Compared with those in the lowest tertile of total cannabis exposure in music, those in the highest tertile of exposure were almost twice as likely to have used cannabis in the past 30 days (odds ratio = 1.83; 95% confidence interval = 1.04, 3.22), even after adjusting for socio-demographic variables, personality characteristics and parenting style. As expected, however, there was no significant relationship between our cannabis exposure variable and a sham outcome variable of alcohol use. Conclusions This study supports an independent association between exposure to cannabis in popular music and early cannabis use among urban American adolescents. [source] Extended treatment of older cigarette smokersADDICTION, Issue 6 2009Sharon M. Hall ABSTRACT Aims Tobacco dependence treatments achieve abstinence rates of 25,30% at 1 year. Low rates may reflect failure to conceptualize tobacco dependence as a chronic disorder. The aims of the present study were to determine the efficacy of extended cognitive behavioral and pharmacological interventions in smokers , 50 years of age, and to determine if gender differences in efficacy existed. Design Open randomized clinical trial. Setting A free-standing, smoking treatment research clinic. Participants A total of 402 smokers of , 10 cigarettes per day, all 50 years of age or older. Intervention Participants completed a 12-week treatment that included group counseling, nicotine replacement therapy (NRT) and bupropion. Participants, independent of smoking status, were then assigned randomly to follow-up conditions: (i) standard treatment (ST; no further treatment); (ii) extended NRT (E-NRT; 40 weeks of nicotine gum availability); (iii) extended cognitive behavioral therapy (E-CBT; 11 cognitive behavioral sessions over a 40-week period); or (iv) E-CBT plus E-NRT (E-combined; 11 cognitive behavioral sessions plus 40 weeks nicotine gum availability). Measurements Primary outcome variable was 7-day point prevalence cigarette abstinence verified biochemically at weeks 24, 52, 64 and 104. Findings The most clinically important findings were significant main effects for treatment condition, time and the treatment × time interaction. The E-CBT condition produced high cigarette abstinence rates that were maintained throughout the 2-year study period [(week 24 (58%), 52 (55%), 64 (55%) and 104 (55%)], and was significantly more effective than E-NRT and ST across that period. No other treatment condition was significantly different to ST. No effects for gender were found. Conclusions Extended cognitive behavioral treatments can produce high and stable cigarette abstinence rates for both men and women. NRT does not add to the efficacy of extended CBT, and may hamper its efficacy. Research is needed to determine if these results can be replicated in a sample with a greater range of ages, and improved upon with the addition of medications other than NRT. [source] Identifying interacting predictors of falling among hospitalized elderly in Japan: A signal detection approachGERIATRICS & GERONTOLOGY INTERNATIONAL, Issue 2 2007Atsuko Nabeshima Falling is a complex phenomenon that involves interaction of multiple risk factors. The authors analyzed factors related to falls in a geriatric hospital to elucidate interaction of multiple risk factors for falls in elderly inpatients. Subjects were 364 patients (mean age, 81.7; women 76.7%) who were aged 60 years and over and had been hospitalized for more than 6 months between April 2000 and March 2001. A signal detection model was used to identify baseline variables that best divided the sample into subgroups using incidence of falling as an outcome variable. During a follow-up period, 91 patients (25%) had at least one incident of fall. Out of 14 independent variables, a higher-order interaction consisting of six significant variables was identified. Consequently, the subjects were categorized into seven subgroups whose fall rate varied 5.7,80.9%. We found that the combination of non-bedridden state, dementia, and medication of tranquilizers or sleeping drugs was the highest fall rate (80.9%). Signal detection analysis is useful to identify the combination of multiple risk factors of falling, and applicable to develop prevention programs for each subgroups. [source] Proliferative activity and diagnostic delay in oral cancerHEAD & NECK: JOURNAL FOR THE SCIENCES & SPECIALTIES OF THE HEAD AND NECK, Issue 10 2010Juan Seoane PhD Abstract Background Tumor stage may relate to the chronology of neoplasm growth and has been used as an outcome variable when studying diagnostic delay in oral cancer. However, tumor growth rate may act as a confounding factor. Methods We reviewed a total of 63 incident cases of oral cancer. The variables considered for the study included age, sex, smoking history, tumor site, TNM stage, Ki-67 score, and diagnostic delay. Results Significant differences between survivors and exitus were found in terms of tumor stage at diagnosis (I,II vs III,IV), sex, and Ki-67 scores. When the analysis was adjusted for tumor stage at diagnosis (I,II vs III,IV), proliferative activity resulted to be an independent prognostic factor for survival, whereas diagnostic delay did not influence survival. Conclusion These results seem to suggest that survival from oral cancer is affected more by the biology of the cancer (rapid tumor growth) than by diagnostic delay. © 2010 Wiley Periodicals, Inc. Head Neck, 2010 [source] Suboccipital Nerve Blocks for Suppression of Chronic Migraine: Safety, Efficacy, and Predictors of OutcomeHEADACHE, Issue 6 2010Silvia Weibelt RN (Headache 2010;50:1041-1044) Background., Approximately 1 in 50 Americans is afflicted by chronic migraine (CM). Many patients with CM describe cervicogenic headache. Options for treating CM effectively are at present quite limited. Objective., To determine the safety and efficacy of occipital nerve blocks (ONBs) used to treat cervicogenic chronic migraine (CCM) and to identify variables predictive of a positive treatment response. Methods., Using a uniform dose and injection paradigm, we performed ONBs consecutively on a series of patients presenting with CCM. Patients were stratified according to specific findings found to be present or absent on physical examination. A positive treatment outcome was defined as a 50% or greater reduction in headache days per month over the 30 days following treatment relative to the 30-day pre-treatment baseline. We used a 5-point Likert scale as one of the secondary outcome variables. Results., We treated 150 consecutive patients with unilateral (37) or bilateral (113) ONBs. At the 1-month follow-up visit 78 (52%) exhibited evidence of a positive treatment response according to the primary outcome variable, and 90 (60%) reported their headache disorder to be "better" (44; 29%) or "much better" (46; 30%). A total of 8 (5%) patients reported adverse events within the ensuing 72 hours, and 3 (2%) experienced adverse events that reversed spontaneously but required emergent evaluation and management. Conclusion., For suppression of CCM, ONBs may offer an attractive alternative to orally administered prophylactic therapy. [source] Lack of effects between rupatadine 10,mg and placebo on actual driving performance of healthy volunteersHUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 5 2007Eric Vuurman Abstract Introduction Rupatadine fumarate is a potent, selective, histamine H1 -receptor antagonist and PAF inhibitor with demonstrated efficacy for the relief of allergic rhinitis. Rupatadine does not easily cross the blood,brain barrier and is believed to be non-sedating at therapeutic doses. Consequently, rupatadine should show no impairment on car driving. Objective This study compared the acute effects of rupatadine, relative to placebo and hydroxyzine (as an active control), on healthy subjects' driving performance. Methods Twenty subjects received a single dose of rupatadine 10,mg, hydroxyzine 50,mg, or placebo in each period of this randomized, double-blind, three-way crossover study. Two hours postdosing, subjects operated a specially instrumented vehicle in tests designed to measure their driving ability. Before and after the driving tests ratings of sedation were recorded. Results There was no significant difference between rupatadine and placebo in the primary outcome variable: standard deviation of lateral position (SDLP); however, hydroxyzine treatment significantly increased SDLP (p,<,0.001 for both comparisons). Objective (Stanford sleepiness scale) and subjective sedation ratings (Visual Analogue Scales) showed similar results: subjects reported negative effects after hydroxyzine but not after rupatadine. Conclusion Rupatadine 10,mg is not sedating and does not impair driving performance. Copyright © 2007 John Wiley & Sons, Ltd. [source] Preoperative determinants of common bile duct stones during laparoscopic cholecystectomyINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 11 2008A. J. Sheen Summary Introduction:, The aim of this study is to determine whether there are any clinical or biochemical predictors of common bile duct (CBD) stones in patients undergoing laparoscopic cholecystectomy. Methods:, A prospective database of nearly 1000 laparoscopic cholecystectomies performed under the care of a single surgeon with a standardised technique between 1999 and 2006, was analysed. Clinical presentation, ultrasound and immediate preoperative biochemical results as well as the operative cholangiogram findings were reviewed. Routine cholangiography was attempted in most patients and the primary outcome variable was the detection of bile duct stones. The data was analysed using chi-squared test for categorical variables. The significant variables on univariate analysis were further characterised to identify the independent predictors of bile duct stones using a logistic regression model (significance p < 0.05). Results:, A total of 757 of 988 patients (77%) underwent cholangiography. Male-to-female ratio was 1 : 3 with a median age of 54 years (range: 17,93). Ten per cent of patients had bile duct stones identified on cholangiography. On univariate analysis, jaundice (p = 0.019), cholangitis (p < 0.001), alanine transaminase > 100 (p = 0.024), alkaline phosphatase (ALP) > 350 (p < 0.001) and CBD > 10 mm (p = 0.01) were significant markers for predicting bile duct stones. Bilirubin > 30 (×2 normal) was found not to be significant (p = 0.145). On a logistic regression model, ALP > 350 and/or cholangitis were found to be independent predictive factors of CBD stones (odds ratio 6.1). Conclusions:, If a policy of routine intra-operative cholangiography is not adopted, a history of cholangitis or a raised ALP immediately preoperatively should lead to a high suspicion of CBD stones. [source] Preparing a large data set for analysis: using the Minimum Data Set to study perineal dermatitisJOURNAL OF ADVANCED NURSING, Issue 4 2005Kay Savik MS Aim., The aim of this paper is to present a practical example of preparing a large set of Minimum Data Set records for analysis, operationalizing Minimum Data Set items that defined risk factors for perineal dermatitis, our outcome variable. Background., Research with nursing home elders remains a vital need as ,baby boomers' age. Conducting research in nursing homes is a daunting task. The Minimum Data Set is a standardized instrument used to assess many aspects of a nursing home resident's functional capability. United States Federal Regulations require a Minimum Data Set assessment of all nursing home residents. These large data would be a useful resource for research studies, but need to be extensively refined for use in most statistical analyses. Although fairly comprehensive, the Minimum Data Set does not provide direct measures of all clinical outcomes and variables of interest. Method., Perineal dermatitis is not directly measured in the Minimum Data Set. Additional information from prescribers' (physician and nurse) orders was used to identify cases of perineal dermatitis. The following steps were followed to produce Minimum Data Set records appropriate for analysis: (1) identification of a subset of Minimum Data Set records specific to the research, (2) identification of perineal dermatitis cases from the prescribers' orders, (3) merging of the perineal dermatitis cases with the Minimum Data Set data set, (4) identification of Minimum Data Set items used to operationalize the variables in our model of perineal dermatitis, (5) determination of the appropriate way to aggregate individual Minimum Data Set items into composite measures of the variables, (6) refinement of these composites using item analysis and (7) assessment of the distribution of the composite variables and need for transformations to use in statistical analysis. Results., Cases of perineal dermatitis were successfully identified and composites were created that operationalized a model of perineal dermatitis. Conclusion., Following these steps resulted in a data set where data analysis could be pursued with confidence. Incorporating other sources of data, such as prescribers' orders, extends the usefulness of the Minimum Data Set for research use. [source] | ||||||||||||||||||||||||||||||||||||||||