nils-herrmann/clean_scirepeval huggingface dataset:
Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial

Trials of beta blockers in patients undergoing non-cardiac surgery have reported conflicting results. This randomised controlled trial, done in 190 hospitals in 23 countries, was designed to investigate the effects of perioperative beta blockers.



We randomly assigned 8351 patients with, or at risk of, atherosclerotic disease who were undergoing non-cardiac surgery to receive extended-release metoprolol succinate (n=4174) or placebo (n=4177), by a computerised randomisation phone service. Study treatment was started 2-4 h before surgery and continued for 30 days. Patients, health-care providers, data collectors, and outcome adjudicators were masked to treatment allocation. The primary endpoint was a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal cardiac arrest. Analyses were by intention to treat. 
All 8351 patients were included in analyses; 8331 (99.8%) patients completed the 30-day follow-up. Fewer patients in the metoprolol group than in the placebo group reached the primary endpoint (244 [5.8%] patients in the metoprolol group vs 290 [6.9%] in the placebo group; hazard ratio 0.84, 95% CI 0.70-0.99; p=0.0399). Fewer patients in the metoprolol group than in the placebo group had a myocardial infarction (176 [4.2%] vs 239 [5.7%] patients; 0.73, 0.60-0.89; p=0.0017). However, there were more deaths in the metoprolol group than in the placebo group (129 [3.1%] vs 97 [2.3%] patients; 1.33, 1.03-1.74; p=0.0317). More patients in the metoprolol group than in the placebo group had a stroke (41 [1.0%] vs 19 [0.5%] patients; 2.17, 1.26-3.74; p=0.0053).



Our results highlight the risk in assuming a perioperative beta-blocker regimen has benefit without substantial harm, and the importance and need for large randomised trials in the perioperative setting. Patients are unlikely to accept the risks associated with perioperative extended-release metoprolol.
Reliability of a Sleep Quality Questionnaire for Use in Epidemiologic Studies

The longer-term health impacts of poor sleep quality are of increasing interest, as evidence suggests that there are rising levels of sleep disturbance in the community. Studies have reported links between sleep quality and increased morbidity and mortality. However, the results of these studies are constrained by limitations in the measurement of sleep quality in epidemiologic studies. The Breast Cancer Environment and Employment Study (BCEES) has developed a sleep questionnaire that attempts to address some of the limitations of previous sleep questionnaires. The present study assessed the test-retest reliability of the sleep questionnaire used in the Breast Cancer Environment and Employment Study (BCEES).



Subjects for this reliability study were women who were participating as controls in the BCEES study. Test-retest reliability was evaluated for individual items, using weighted kappa for categorical variables and intraclass correlation coefficients (ICC) and limits of agreement for continuous variables.



Most sleep questions showed good agreement, ranging from 0.78 to 0.45. The ICC was 0.45 (95% CI 0.32-0.59) for lifetime sleep loss per year and 0.60 (95% CI 0.49-0.71) for symptom severity.



The test-retest reliability of the general sleep questions was good, and future epidemiologic studies of sleep could reliably expand the number of assessed domains of sleep quality. However, reliability decreased as increasing detail was required from participants about specific periods of sleep disturbance, and changes to the questionnaire are warranted.
Should we resurface the patella in total knee replacement?

Patellar resurfacing is a controversial issue in primary total knee replacement. So, we took advantage of a large study to try and answer this question. An open prospective multicentric study was conducted about the outcome of the Nex Gen Total Knee prosthesis with clinical and radiological follow-up at regular intervals (1, 2 and 5 years). The data were centrally collected and analyzed by independent observers. A total of whole 5,915 cases were included (487 in the French group); incidences of patello-femoral pain were observed in both French and international groups and compared between cases with or without resurfaced patellae. Only osteoarthritic cases were selected for this particular study. Statistical analysis was performed using a Pearson’s Chi-square test with a 95% confidence interval. The frequency of preoperative pain was significantly higher in the French group; 85.1% versus 66.6% (p<0.05). No patello-femoral pain appeared in preoperatively painless patients in the French group. The frequency of lateral patellar release was similar in both groups. 35.7% of the patellae were resurfaced in the international group versus 98.8% in the French one. At 2 years, patello-femoral pain was observed in 6.3% of cases in the former group versus 0.7% in the latter one. The risk of having patello-femoral pain was 9.45 times higher in the international group. When considering resurfaced cases in both groups the risk of having anterior knee pain was not significantly different (p=0.35). In the French group, one case out of nine (11.1%) with patello-femoral pain had not been resurfaced, while 129 cases out of 151 (85.4%) had not had a resurfacing in the international group. This emphasizes the effect of patellar implant on pain. Although patello-femoral pain is multifactorial, this analysis tool is powerful in getting rid of the “center effect ” (cf Swedish register). Even if a longer follow-up for confirmation is needed, our data favor patellar resurfacing with this type of implant in spite of the fact that the trochlear design was considered as anatomical.
The effectiveness of a graphical presentation in addition to a frequency format in the context of familial breast cancer risk communication: a multicenter controlled trial

Inadequate understanding of risk among counselees is a common problem in familial cancer clinics. It has been suggested that graphical displays can help counselees understand cancer risks and subsequent decision-making. We evaluated the effects of a graphical presentation in addition to a frequency format on counselees' understanding, psychological well-being, and preventive intentions.



Multicenter controlled trial.



Three familial cancer clinics in the Netherlands.



Unaffected women with a breast cancer family history (first-time attendees).



Immediately after standard genetic counseling, an additional consultation by a trained risk counselor took place where women were presented with their lifetime breast cancer risk in frequency format (X out of 100) (n = 63) or frequency format plus graphical display (10 × 10 human icons) (n = 91).



understanding of risk (risk accuracy, risk perception), psychological well-being, and intentions regarding cancer prevention. Measurements were assessed using questionnaires at baseline, 2-week and 6-month follow-up.



Baseline participant characteristics did not differ between the two groups. In both groups there was an increase in women's risk accuracy from baseline to follow-up. No significant differences were found between women who received the frequency format and those who received an additional graphical display in terms of understanding, psychological well-being and intentions regarding cancer prevention. The groups did not differ in their evaluation of the process of counseling.



Women's personal risk estimation accuracy was generally high at baseline and the results suggest that an additional graphical display does not lead to a significant benefit in terms of increasing understanding of risk, psychological well-being and preventive intentions.
Incidence and predictors of cognitive decline in patients with left ventricular assist devices.

After left ventricular assist device (LVAD) placement for advanced heart failure, increased cerebral perfusion should result in improved cognitive function. However, stroke (a well-known LVAD complication) and subclinical cerebral ischemia may result in transient or permanent cognitive decline. We sought to describe the incidence and predictors of cognitive decline after LVAD using a valid, sensitive assessment tool.



Among 4419 patients in the Interagency Registry for Mechanically Assisted Circulatory Support who underwent LVAD implantation between May 2012 and December 2013, cognitive function was assessed in 1173 patients with the Trail Making B Test before LVAD and at 3, 6, and 12 months. The test detects several forms of cognitive impairment, including subclinical stroke. Cognitive decline was defined as a clinically important increase during follow-up using a moderate Cohen d effect size of 0.5×baseline SD (32 s). The cumulative incidence of cognitive decline in the year after LVAD implantation, treating death and transplantation as competing risks, was 29.2%. In adjusted analysis, older age (≥70 versus <50 years; hazard ratio, 2.24; 95% confidence interval 1.46-3.44; P(trend)<0.001) and destination therapy (hazard ratio, 1.42; 95% confidence interval, 1.05-1.92) were significantly associated with greater risk of cognitive decline.



Cognitive decline occurs commonly in patients in the year after LVAD and is associated with older age and destination therapy. These results could have important implications for patient selection and improved communication of risks before LVAD implantation. Additional studies are needed to explore the association between cognitive decline and subsequent stroke, health status, and mortality in patients after LVAD.
The Effects of Testosterone Supplementation on Cognitive Functioning in Older Men

Reduction in testosterone levels in men during aging is associated with cognitive decline and risk of dementia. Animal studies have shown benefits for testosterone supplementation in improving cognition and reducing Alzheimer's disease pathology. In a randomized, placebo-controlled, crossover study of men with subjective memory complaint and low testosterone levels, we investigated whether testosterone treatment significantly improved performance on various measures of cognitive functioning. Forty-four men were administered a battery of neuropsychological tests to establish the baseline prior to being randomly divided into two groups. The first group (Group A) received 24 weeks of testosterone treatment (T treatment) followed by 4 weeks washout, and then 24 weeks of placebo (P); the second group (Group B) received the same treatments, in reverse order (Placebo, washout, and then T treatment). In group A (TèP), compared to baseline, there was a modest (1 point) but significant improvement in general cognitive functioning as measured by the Mini Mental State Examination (MMSE) following testosterone treatment. This improvement from baseline was sustained following the washout period and crossover to placebo treatment. Similar Mini Mental State Examination (MMSE) scores were observed when comparing testosterone treatment with placebo. In group B (PèT) a significant increase was observed from baseline following testosterone treatment and a trend towards an increase when compared to placebo treatment. Improvements in baseline depression scores (assessed by Geriatric Depression Scale) were observed following testosterone/placebo treatment in both groups, and no difference was observed when comparing testosterone with placebo treatment. Our findings indicate a modest improvement on global cognition with testosterone treatment. Larger clinical trials with a longer follow- up and with the inclusion of blood and brain imaging markers are now needed to conclusively determine the significance of testosterone treatment.
The responsiveness and correlation between Fugl-Meyer Assessment, Motor Status Scale, and the Action Research Arm Test in chronic stroke with upper-extremity rehabilitation robotic training.

Responsiveness of clinical assessments is an important element in the report of clinical effectiveness after rehabilitation. The correlation could reflect the validity of assessments as an indication of clinical performance before and after interventions. This study investigated the correlation and responsiveness of Fugl-Meyer Assessment (FMA), Motor Status Scale (MSS), Action Research Arm Test (ARAT) and the Modified Ashworth Scale (MAS), which are used frequently in effectiveness studies of robotic upper-extremity training in stroke rehabilitation. Twenty-seven chronic stroke patients were recruited for a 20-session upper-extremity rehabilitation robotic training program. This was a rater-blinded randomized controlled trial. All participants were evaluated with FMA, MSS, ARAT, MAS, and Functional Independent Measure before and after robotic training. Spearman's rank correlation coefficient was applied for the analysis of correlation. The standardized response mean (SRM) and Guyatt's responsiveness index (GRI) were used to analyze responsiveness. Spearman's correlation coefficient showed a significantly high correlation (ρ=0.91-0.96) among FMA, MSS, and ARAT and a fair-to-moderate correlation (ρ=0.40-0.62) between MAS and the other assessments. FMA, MSS, and MAS on the wrist showed higher responsiveness (SRM=0.85-0.98, GRI=1.59-3.62), whereas ARAT showed relatively less responsiveness (SRM=0.22, GRI=0.81). The results showed that FMA or MSS would be the best choice for evaluating the functional improvement in stroke studies on robotic upper-extremity training with high responsiveness and good correlation with ARAT. MAS could be used separately to evaluate the spasticity changes after intervention in terms of high responsiveness.
Treatment of asthma with nebulized lidocaine: a randomized, placebo-controlled study.

In 2 prior uncontrolled studies, nebulized lidocaine reduced oral glucocorticoid use in patients with severe glucocorticoid-dependent asthma.



We tested the safety and efficacy of nebulized lidocaine in a randomized, placebo-controlled study in patients with mild-to-moderate asthma.



We recruited 50 subjects (25 receiving lidocaine and 25 receiving placebo); all had a prebronchodilator FEV(1) of 64% to 125% of predicted normal value and were treated with daily inhaled glucocorticoids (but not systemic glucocorticoids) and bronchodilators for at least 2 months. Before treatment, subjects monitored their symptoms and peak flow values and maintained their medications for 2 weeks. At initiation, subjects inhaled either nebulized placebo (saline) or lidocaine (4%, 100 mg) 4 times daily. All subjects were instructed to reduce their inhaled glucocorticoid dosage by one half each week for 3 weeks and to discontinue glucocorticoid treatment at week 4. The subjects continued the nebulized lidocaine or placebo for a total of 8 weeks, monitored their symptoms, and used bronchodilators to control symptoms.



Indicators of asthma severity showed benefit for the lidocaine-treated group: changes in FEV(1) (P < or =.001), nighttime awakenings (P < or =.02), symptoms (P < or =.010), bronchodilator use (P < or =.010), and blood eosinophil counts (P < or =.020). Subjects in both groups reduced use of inhaled glucocorticoids comparably. Subjects receiving nebulized placebo showed increases in their symptom scores, bronchodilator use (P < or =.05 for both), and blood eosinophil counts (P < or =.01) and decreases in FEV(1) (P < or =.001).



Nebulized lidocaine provided effective and safe therapy in subjects with mild-to-moderate asthma.
Intravenous application of omega-3 fatty acids in patients with active rheumatoid arthritis. The ORA-1 trial. An open pilot study

The objective of this work was to assess the therapeutic efficacy and to lerability of intravenously applied n-3-PUFA in patients with active rheumatoid arthritis (RA). Thirty-four patients with active RA [identified as having a DAS28 (disease activity score including a 28 joint count) >4.0] were enrolled into this 5-wk open pilot study (one group design). From the time of screening (visit 0, or V0), background therapy had to remain unchanged. Patients received 2 mL/kg(=0.1–0.2 g fish oil/kg) fish oil emulsion intravenously on 7 consecutive days (Visit 1–Visit 2, or V1–V2) in addition to their background therapy. A decrease of the DAS28>0.6 at day 8 (Visit 2) was the primary efficacy measure. Moreover, the DAS28 at day 35 (Visit 3, or V3), the modified Health Assessment Questionnaire, the American College of Rheumatology (ACR) response criteria (V2, V3) and the Short Form-36 (V3) were assessed. Thirty-three patients completed the trial. The mean DAS28 at V1 was 5.45; at V2, 4.51 (P<.001 V1–V2) and at V3, 4.73 (P<.001 V1–V3; V2–V3, not significantly different). Of the 34 patients, 56% achieved a reduction of the DAS28>0.6 at V2 (mean 1.52); 27%>1.2. At V3, 41% of the patients showed a DAS28 reduction >0.6 (mean 1.06), and 36%>1.2. ACR 20 and 50% responses at V2 were seen in 29 and 12% of patients, respectively; at V3, the comparable values were 18 and 9%, respectively. Overall tolerability was excellent. Intravenous application of n-3-PUFA (as an add-on therapy) was considerably well tolerated and led to improvement of the disease activity status in a reasonable number of RA patients. Future trials are warranted to answer whether the intravenous application of n-3-PUFA constitutes a therapeutic option in RA patients.
Fludarabine treatment of patients with chronic lymphocytic leukemia induces a p53-dependent gene expression response.

Fludarabine, the current standard treatment for B-cell chronic lymphocytic leukemia (CLL), can induce apoptosis in CLL cells in vitro, and a number of molecular mechanisms contribute to its cytotoxicity. Using gene expression profiling, we investigated the molecular consequences of fludarabine treatment of patients with CLL in vivo. In 7 patients with CLL, a consistent gene expression signature of in vivo fludarabine exposure was identified. Many of the fludarabine signature genes were known p53 target genes and genes involved in DNA repair. In vitro treatment of CLL cells with fludarabine induced the same set of genes as observed in vivo, and many of these genes were also induced by in vitro exposure of CLL cells to ionizing radiation. Using isogenic p53 wild-type and null lymphoblastoid cell lines, we confirmed that many of the fludarabine signature genes were also p53 target genes. Because in vivo treatment with fludarabine induces a p53-dependent gene expression response, fludarabine treatment has the potential to select p53-mutant CLL cells, which are more drug resistant and associated with an aggressive clinical course. These considerations suggest that fludarabine treatment should be given in strict accordance to the current National Cancer Institute (NCI) guidelines that have established criteria of disease activity that warrant treatment.
Green software services: From requirements to business models

In recent years, green software research is gaining momentum because of the acute need for sustainable development. Most past research has been focused on the definitions, metrics and technical solutions for green software, but few has addressed green software from the business perspective. In this paper, we present the analysis on three key elements of Green Software Services (GSS)---stakeholders, their requirements, and business models. The stakeholders of GSS are detailed with the services each stakeholder can provide and consume, thus clarifying their interests to GSS. Based on this analysis, we present the domain-independent, high-level requirements to GSS that cover diverse needs of different stakeholders. Six business models are then proposed to promote collaborations of stakeholders on the delivery of GSS. In the end, the relationship between GSS and cloud is discussed and a GSS marketplace is envisioned.
Comparison of the effects of four commercially available weight-loss programmes on lipid-based cardiovascular risk factors.

To investigate the relative efficacy of four popular weight-loss programmes on plasma lipids and lipoproteins as measures of CVD risk.



A multi-centred, randomised, controlled trial of four diets - Dr Atkins' New Diet Revolution, The Slim-Fast Plan, Weight Watchers Pure Points programme and Rosemary Conley's 'Eat yourself Slim' Diet and Fitness Plan - against a control diet, in parallel for 6 months.



The trial was conducted at five universities across the UK (Surrey, Nottingham, Ulster (Coleraine), Bristol and Edinburgh (Queen Margaret University College)) and involved the participation of 300 overweight and obese males and females aged 21-60 years in a community setting.



Significant weight loss was achieved by all dieting groups (5-9 kg at 6 months) but no significant difference was observed between diets at 6 months. The Weight Watchers and Rosemary Conley (low-fat) diets were followed by significant reductions in plasma LDL cholesterol (both -12.2 % after 6 months, P < 0.01), whereas the Atkins (low-carbohydrate) and Weight Watchers diets were followed by marked reductions in plasma TAG (-38.2 % and -22.6 % at 6 months respectively, P < 0.01). These latter two diets were associated with an increase in LDL particle size, a change that has been linked to reduced CVD risk.



Overall, these results demonstrate the favourable effects of weight loss on lipid-mediated CVD risk factors that can be achieved through commercially available weight-loss programmes. No detrimental effects on lipid-based CVD risk factors were observed in participants consuming a low-carbohydrate diet.
The EUROHIS-QOL 8-item index: comparative psychometric properties to its parent WHOQOL-BREF.

To test the psychometric properties of the EUROHIS-QOL 8-item index, a shortened version of the World Health Organization Quality of Life Instrument-Abbreviated Version (WHOQOL-BREF).



The sample consisted of 2359 subjects identified from primary care settings, with 1193 having a confirmed diagnosis of depression. Data came from six countries (Australia, Brazil, Israel, Russia, Spain, and the United States) involved in a large international study, the Longitudinal Investigation of Depression Outcomes. The structure of the EUROHIS-QOL 8-item index follows that of the WHOQOL-BREF assessment. Internal consistency was measured by using Cronbach's alpha. Convergent validity was assessed by using correlations with different measures for mental health (Symptom Checklist 90), physical health (self-evaluation), and quality of life (WHOQOL-BREF and short form 36 health survey). Discriminant group validity was assessed between diagnosed depressed and nondepressed patients. Differential item functioning and unidimensionality were analyzed by using Rasch analysis. Factor structure was assessed with structural equation modeling analyses.



Internal consistency was acceptable (ranged between 0.72 and 0.81 across countries), and the index discriminated well between depression (t = 6.31-20.33; P < 0.001) across all countries. Correlations between the EUROHIS-QOL 8-item index and different measures--Symptom Checklist 90 (r = -0.42), physical health (r = -0.42), WHOQOL-BREF domains (r = 0.61-0.77), and short form 36 health survey (r = 0.58)--were all significant (P < 0.001). The index is unidimensional with desired item fit statistics. Two items ("daily living activities" and "enough money to meet your needs") had residuals exceeding 4. Differential item functioning was observed with general quality of life, general health, relationships, and home items for age. A common one-factor structure with acceptable fit was identified in three out of six countries (comparative fit index = 0.85, root mean square error of approximation = 0.11).



The EUROHIS-QOL 8-item index showed acceptable cross-cultural performance and a satisfactory discriminant validity and would be a useful measure to include in studies to assess treatment effectiveness.