nils-herrmann/clean_scirepeval huggingface dataset:
Can analyses of electronic patient records be independently and externally validated? Study 2—the effect of β-adrenoceptor blocker therapy on cancer survival: a retrospective cohort study

To conduct a fully independent, external validation of a research study based on one electronic health record database using a different database sampling from the same population.



Retrospective cohort analysis of β-blocker therapy and all-cause mortality in patients with cancer.



Two UK national primary care databases (PCDs): the Clinical Practice Research Datalink (CPRD) and Doctors' Independent Network (DIN).



CPRD data for 11,302 patients with cancer compared with published results from DIN for 3462 patients; study period January 1997 to December 2006.



All-cause mortality: overall; by treatment subgroup (β-blockers only, β-blockers plus other blood pressure lowering medicines (BPLM), other BPLMs only); and by cancer site.



Using CPRD, β-blocker use was not associated with mortality (HR=1.03, 95% CI 0.93 to 1.14, vs patients prescribed other BPLMs only), but DIN β-blocker users had significantly higher mortality (HR=1.18, 95% CI 1.04 to 1.33). However, these HRs were not statistically different (p=0.063), but did differ for patients on β-blockers alone (CPRD=0.94, 95% CI 0.82 to 1.07; DIN=1.37, 95% CI 1.16 to 1.61; p<0.001). Results for individual cancer sites differed by study, but only significantly for prostate and pancreas cancers. Results were robust under sensitivity analyses, but we could not be certain that mortality was identically defined in both databases.



We found a complex pattern of similarities and differences between databases. Overall treatment effect estimates were not statistically different, adding to a growing body of evidence that different UK PCDs produce comparable effect estimates. However, individually the two studies lead to different conclusions regarding the safety of β-blockers and some subgroup effects differed significantly. Single studies using even internally well-validated databases do not guarantee generalisable results, especially for subgroups, and confirmatory studies using at least one other independent data source are strongly recommended.
The effects of strength training among persons with hand osteoarthritis: a two-year follow-up study.

Hand exercise is recommended for hand osteoarthritis (OA) management, but few efficacy studies have been published. The purpose of the study was to determine the effects of two years of whole body strength training and gripper exercise on hand strength, pain, and function in adults with radiographic evidence of hand OA. Older adults (N=55; 71.5+/-6.5 years; 80% female) participated in a two-year, three times per week strength training regimen. Bilateral gripper exercise weight (i.e., isotonic grip strength), isometric grip strength, pain, and self-reported hand, and finger function were recorded at baseline and 24 months. Isotonic grip strength increased 1.94 kg (20.14 kg baseline, 22.09 kg follow-up; p<0.0003). Right and left isometric grip increased 3.62 kg (25.83 kg baseline, 29.45 kg follow-up; p<0.002) and 2.95 kg (22.73 kg baseline, 25.65 kg follow-up; p<0.0005), respectively. Hand pain decreased from 4.77 to 2.62 (p<0.006). Hand and finger function scores showed minimal dysfunction at baseline and follow-up. Results suggest strength training safely increases dynamic and static grip strength and reduces pain in older persons with hand OA.
The metabolic syndrome, circulating oxidized LDL, and risk of myocardial infarction in well-functioning elderly people in the health, aging, and body composition cohort.

The object of this study was to establish the association between the metabolic syndrome and oxidized LDL (oxLDL) and to determine the risk for coronary heart disease (CHD) in relation to the metabolic syndrome and levels of oxLDL. OxLDL was measured in plasma from 3,033 elderly participants in the Health, Aging, and Body Composition study. The metabolic syndrome was defined according to criteria established in the Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. We observed that the metabolic syndrome was associated with higher levels of oxLDL due to a higher fraction of oxLDL, not to higher levels of LDL cholesterol. Individuals with the metabolic syndrome had twice the odds of having high oxLDL (>1.90 mg/dl) compared with those not having the metabolic syndrome, after adjusting for age, sex, ethnicity, smoking status, and LDL cholesterol. Among those participants who had the metabolic syndrome at study entry, incidence rates of future CHD events were 1.6-fold higher, after adjusting for age, sex, ethnicity, and smoking status. OxLDL was not an independent predictor of total CHD risk. However, those with high oxLDL showed a greater disposition to myocardial infarction (relative risk 2.25, 95% confidence interval 1.22-4.15). We concluded that the metabolic syndrome, a risk factor for CHD, is associated with higher levels of circulating oxLDL that are associated with a greater disposition to atherothrombotic coronary disease.
Impact of a patent foramen ovale on paroxysmal atrial fibrillation ablation.

A patent foramen ovale (PFO) is located at the anterior and superior part of the anatomical interatrial septum, the area that is targeted during transseptal puncture. This study sought to investigate the impact of accessing the left atrium via a PFO on paroxysmal AF ablation.



From March 2004, 203 patients (55 +/- 11 years) underwent catheter ablation for paroxysmal AF (80 +/- 71 months), with the endpoint being electrical isolation of all pulmonary veins (PV) and AF noninducibility. The presence of a PFO was determined by both transesophageal echocardiography and catheter probing. Procedural difficulty was evaluated by radiofrequency (RF), procedural, and fluoroscopic durations. Clinical follow-up was also investigated.



A PFO was detected in 27 patients (13%) by transesophageal echocardiography and in 22 additional patients (total 49 patients, 24%), by catheter probing (P < 0.001). A PFO was associated with longer total RF applications (57 +/- 19 vs 51 +/- 18 min, P = 0.04) and RF applications to isolate the PVs (42 +/- 16 vs 35 +/- 12 min, P = 0.001). Procedural and fluoroscopic times were unaffected. Seventy-three patients (36%) required a second procedure; there was no difference in the number of PV reconnections (1.3 vs 1.8 veins, P = NS). After a mean follow-up of 19 +/- 9 months, 194/203 patients (96%) were free of AF, with no difference in patients in whom a PFO had been used.



Although isolation of PVs is longer, overall procedural duration and success is not affected when using a PFO compared with a transseptal puncture. The presence of a PFO is underestimated by transesophageal echocardiography with brachial injection when compared with catheter probing.
Trials in advanced Hodgkin's disease: asking the right questions at the right time

The treatment of advanced Hodgkin’s disease poses unique lenges for those involved in the design of randomized clin trials. The disease predominantly affects young adults, app imately 70% of whom are likely to be cured by modern f line combination chemotherapy (Canellos et al, 1992). Late effects of treatment, particularly gonadal toxicity and the risk secondary myelodysplasia and acute myeloid leukaemia (M AML), are major issues for long-term survivors. In view of the high response and cure rates, randomized tria this disease must recruit large numbers of patients to adequate statistical power. Attempts to improve response survival rates by intensifying initial chemotherapy must balanced against the potential for long-term toxicity. In view of effectiveness of salvage therapy, particularly high-dose the and autologous stem cell transplantation (ASCT) (Linch e 1993; Sweetenham et al, 1997; Yuen et al, 1997; Lazarus 1999) intensified initial therapy may only be appropriate patients with adverse prognostic factors at presentation. The stakes are high for a young adult with advanced Hodg disease. When asked to participate in a clinical trial, the pa must be reassured that this trial is asking a relevant question his or her chances of long-term survival will not be comprom by participating in the trial, and that the potential long-term c sequences of the treatment will be addressed. The resu the British National Lymphoma Investigation (BNLI)/Centr Lymphoma Group (CLG) randomized trial reported in this issu the British Journal of Cancer(Hancock et al, 2001) should b judged against these criteria. This study was initiated in 199 about the same time that Cancer and Leukemia Group B (CAL reported the results of a randomized trial comparing AB (doxorubicin, bleomycin, vinblastine, dacarbazine), MO (mustine, vincristine, procarbazine, prednisone), and altern MOPP/ABVD in 361 patients (Canellos et al, 1992). Respo failure-free and overall-survival rates were equivalent for AB and MOPP/ABVD. Both were superior to MOPP alone. Since publication of this study, ABVD has been widely regarded ‘standard’ chemotherapy for advanced Hodgkin’s disease. The BNLI/CLG trial compared an alternating ‘variant’ MOPP/ABVD, known as ChlVPP/PABIOE (chlorambucil, vi blastine, procarbazine, prednisone/prednisone, doxorubicin, mycin, vincristine, etoposide) with PABIOE alone. The origi phase II multicentre trial of the ChlVPP/PABIOE regimen p radiotherapy reported 5 year FFS and OS rates of 68% and respectively (Cullen et al, 1994). These results are comparab MOPP/ABVD. The authors’ rationale for a randomized comparison of regimen with PABIOE alone was 2-fold. Firstly, the CALGB stu was relatively small and lacked sufficient power to conf halal xt ef S/
Avoidance, Anxiety, and Sex: The Influence of Romantic Attachment on HIV-Risk among Pregnant Women

Most unprotected sex occurs in close relationships. However, few studies examine relational factors and sexual risk among high-risk populations. Romantic Attachment Theory states that individuals have cognitive working models for relationships that influence expectations, affect, and behavior. We investigated the influence of attachment avoidance and anxiety on sexual beliefs (e.g., condom use beliefs, self-efficacy), behavior (e.g., condom use, multiple partners, unprotected sex with risky partners), and sexually transmitted infections (STIs) among 755 high-risk, young pregnant women (ages 14â€“25) recruited from urban prenatal clinics. Attachment anxiety predicted sexual beliefs, condom use, and unprotected sex with risky partners controlling for demographic variables. Sexual beliefs did not mediate the relationship between attachment orientation and sexual behavior. Current relationship with the father of the baby did mediate the effect of attachment anxiety on multiple partners and STIs. Results indicate the importance of including general relational factors, such as attachment, in HIV prevention.
A randomized placebo-controlled trial of risperidone for the treatment of aggression, agitation, and psychosis of dementia.

This randomized, double-blind, placebo-controlled trial examined the efficacy and safety of risperidone in the treatment of aggression, agitation, and psychosis in elderly nursing-home patients with dementia.



Elderly patients with a DSM-IV diagnosis of dementia of the Alzheimer's type, vascular dementia, or a combination of the 2 (i.e., mixed dementia) and significant aggressive behaviors were randomized to receive, for a period of 12 weeks, a flexible dose of either placebo or risperidone solution up to a maximum of 2 mg/day. Outcome measures were the Cohen-Mansfield Agitation Inventory (CMAI), the Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD) rating scale, and the Clinical Global Impression of Severity (CGI-S) and of Change (CGI-C) scales.



A total of 345 patients were randomized to treatment with risperidone or placebo, and 337 patients received at least one dose of study drug. The trial was completed by 67% of patients in the placebo group and 73% of patients in the risperidone group. The mean +/- SE dose of risperidone was 0.95 +/- 0.03 mg/day. The primary endpoint of the study, the difference from baseline to endpoint in CMAI total aggression score, showed a significant reduction in aggressive behavior for risperidone versus placebo (p <.001). A similar improvement was also seen for the CMAI total non-aggression subscale (p <.002) and for the BEHAVE-AD total (p <.001) and psychotic symptoms subscale (p =.004). At endpoint, the CGI-S and the CGI-C scores indicated a significantly greater improvement with risperidone compared with placebo (p <.001). Overall, 94% and 92% of the risperidone and placebo groups, respectively, reported at least 1 adverse event. Somnolence and urinary tract infection were more common with risperidone treatment, whereas agitation was more common with placebo. There was no significant difference in the number of patients who reported extrapyramidal symptoms between the risperidone (23%) and placebo (16%) groups.



Treatment with low-dose (mean = 0.95 mg/day) risperidone resulted in significant improvement in aggression, agitation, and psychosis associated with dementia.
Association of fitness with vascular intima-media thickness and elasticity in adolescence.

Vascular intima-media thickness (IMT) and elasticity are surrogate markers of atherosclerosis. Data on the effect of cardiorespiratory fitness on these measures of vascular health in adolescence are scarce. The aim was to examine the association of fitness with aortic and carotid artery IMT and elasticity in adolescents.



Aortic (n = 449) and carotid (n = 467) IMT and elasticity were measured ultrasonographically in 17-year-old adolescents participating in a prospective, longitudinal atherosclerosis prevention study (Special Turku Coronary Risk Factor Intervention Project). Distensibility and Young's elastic modulus (YEM) were used as measures of arterial elasticity. Cardiorespiratory fitness (maximum oxygen uptake, mL/kg/min) was measured with a maximal cycle ergometer test. Data on fitness were available for 341 of adolescents with aortic and 355 with carotid ultrasound measures.



Fitness was inversely associated with aortic IMT (β[SE] = -0.0029[0.0013]; P = .031) and YEM  = -0.012[0.0053]; P = .025) after adjusting for gender, physical activity, high-density lipoprotein/total cholesterol, triglycerides, high-sensitivity C-reactive protein, homeostasis model of assessment-insulin resistance, BMI, systolic blood pressure, and smoking. Risk of having low aortic distensibility (≤10th percentile) decreased with increasing fitness (odds ratio = 0.89, 95% confidence interval 0.82-0.98); P = .014). The increase in aortic IMT and YEM between ages 11 and 17 years was smaller in adolescents who were fit at age 17 compared with adolescents who had the lowest fitness level (P for IMT = .015, P for YEM = .0072). Fitness was not associated with carotid IMT or elasticity. Lifestyle counseling given in the Special Turku Coronary Risk Factor Intervention Project was not associated with fitness.



Fitness was favorably associated with aortic IMT and elasticity in adolescents. No association of fitness with the respective carotid indices was found. These data suggest that fitness in part enhances vascular health in healthy adolescents.
The effectiveness of a self-efficacy-enhancing intervention for Chinese patients with colorectal cancer: a randomized controlled trial with 6-month follow up.

Colorectal cancer is a major public health problem. There is growing support for colorectal cancer survivors who are experiencing problems after cancer treatment to engage in self-management programs to reduce symptom distress. However, there is inconclusive evidence as to the effectiveness of such program especially in Asian region.



This study tested the effects of a six-month nurse-led self-efficacy-enhancing intervention for patients with colorectal cancer, compared with routine care over a six-month follow up.



A randomized controlled trial with repeated measures, two-group design.



Three teaching hospitals in Guangzhou, China.



One hundred and fifty-two Chinese adult patients with a diagnosis of colorectal cancer were recruited. The intervention group (n=76) received self-efficacy-enhancing intervention and the control group (n=76) received standard care.



The participants were randomized into either intervention or control group after baseline measures. The outcomes of the study (self-efficacy, symptom distress, anxiety, depression and quality of life) were compared at baseline, three and six months after the intervention.



Sixty-eight participants in the intervention group and 53 in the control group completed the study. Their mean age was 53 (SD=11.3). Repeated measure MANOVA found that the patients in the intervention group had significant improvement in their self-efficacy (F=7.26, p=0.003) and a reduction of symptom severity (F=5.30, p=0.01), symptom interference (F=4.06, p=0.025), anxiety (F=6.04, p=0.006) and depression (F=6.96, p=0.003) at three and six months, compared with the control group. However, no statistically significant main effect was observed in quality of life perception between the two groups.



The nurse-led self-efficacy enhancing intervention was effective in promoting self-efficacy and psychological well-being in patients with colorectal cancer, compared with standard care. The intervention can be incorporated into routine care. Future empirical work is required to determine the longer term effects of the intervention.
Identification of coronary plaque sub-types using virtual histology intravascular ultrasound is affected by inter-observer variability and differences in plaque definitions.

Recent studies show that virtual histology intravascular ultrasound (VH-IVUS) can identify plaques at high risk of rupture, such as thin-capped fibroatheromata, raising the possibility of immediate targeted intervention. However, plaque classification entails border recognition and subjective assessment of plaque architecture, introducing inter-observer variability without confirmation by core-labs. Furthermore, the accuracy of local versus core-laboratory VH-IVUS plaque classification and effects of different plaque definitions have not been examined.



Local observers classified 100 VH-IVUS-defined coronary plaques to determine single center inter-observer variability; multi-center variability was determined by comparison with VH-IVUS core-laboratory analysis, and compared with gray-scale IVUS. Frequency of plaque types using different published plaque definitions also was determined. Single-center VH-IVUS inter-observer agreement was strong (kappa=0.86), but lower for thin-capped fibroatheromatas (k=0.59) because of observer judgments on presence and location of confluent necrotic core. Multi-center inter-observer agreement for plaque classification was lower again (k=0.71), particularly for thin-capped fibroatheromatas (k=0.56). Different plaque definitions further reduced VH-IVUS-defined thin-capped fibroatheromata numbers by 44%. The diagnostic accuracy of gray-scale IVUS to identify thin-capped fibroatheromata was poor for both observers (21 and 29% correct), with low inter-observer agreement (k=0.14).



VH-IVUS plaque classification, and particularly VH-IVUS-defined thin-capped fibroatheromata identification, varies significantly between local observers, and particularly in comparison with core-laboratory analysis. Differences in VH-IVUS plaque definitions introduce further variability between studies. These factors reduce the use of VH-IVUS plaque classification to guide intervention in a "live" clinical setting, and also affect comparison of diagnostic accuracy and natural history of plaques between studies.
Randomized clinical trial to evaluate the effect of a supervised exercise training program on readmissions in patients with myocardial ischemia: a study protocol

In recent decades, several studies have assessed the value of cardiac rehabilitation as secondary prevention and have reported substantial reductions in readmissions. However, conclusive evidence is scarce. The present study aims to evaluate the efficacy of a supervised exercise training program for improving percentages of hospital readmission for cardiac causes in patients with myocardial ischemia in the first year after a cardiac event. The effect on all-cause readmission, all-cause mortality, functional capacity, quality of life and adherence to regular exercise is also discussed.



This study will be conducted as a randomized controlled trial. Eligible patients will be randomly assigned to a control group receiving standard care or to an intervention group which, in addition to standard care, will take part in a supervised exercise training program consisting of three hours a week (spread over three alternate days) of supervised exercise training for 10 weeks. Both groups will perform an exercise stress test and a blood test during the first and third month after hospital discharge. The follow-up period will be 12 months after hospital discharge. The primary outcome measures will be the percentage of patients readmitted, total number of readmissions and length of hospitalization for cardiac disease during the first year after hospital discharge, and time to first hospital admission for cardiac disease.



A representative group of hospitalized patients after myocardial ischemia will be studied in order to provide comprehensive data on the potential impact of a supervised exercise training program on hospital readmission rates.
Additive glucose-lowering effects of glucagon-like peptide-1 and metformin in type 2 diabetes.

The incretin hormone glucagon-like peptide-1 (GLP-1) reduces plasma glucose in type 2 diabetic patients by stimulating insulin secretion and inhibiting glucagon secretion. The biguanide metformin is believed to lower plasma glucose without affecting insulin secretion. We conducted this study to investigate the effect of a combination therapy with GLP-1 and metformin, which could theoretically be additive, in type 2 diabetic patients.



In a semiblinded randomized crossover study, seven patients received treatment with metformin (1,500 mg daily orally) alternating with GLP-1 (continuous subcutaneous infusion of 2.4 pmol x kg(-1) x min(-1)) alternating with a combination of metformin and GLP-1 for 48 h. Under fixed energy intake, we examined the effects on plasma glucose, insulin, C-peptide, glucagon, and appetite.



Fasting plasma glucose (day 2) decreased from 13.9 +/- 1 (no treatment) to 11.2 +/- 0.4 (metformin) and 11.5 +/- 0.5 (GLP-1) and further decreased to 9.4 +/- 0.7 (combination therapy) (P = 0.0005, no difference between monotherapy with GLP-1 and metformin). The 24-h mean plasma glucose (day 2) decreased from 11.8 +/- 0.5 (metformin) and 11.7 +/- 0.8 (GLP-1) to 9.8 +/- 0.5 (combination) (P = 0.02, no difference between GLP-1 and metformin). Insulin levels were similar between the three regimens, but glucagon levels were significantly reduced with GLP-1 compared with metformin (P = 0.0003). Combination therapy had no additional effect on appetite scores.



Monotherapy with GLP-1 and metformin have equal effects on plasma glucose and additive effects upon combination.