nils-herrmann/clean_scirepeval huggingface dataset:
Postal Administration Compared with Nurse-Supported Administration of the QUALEFFO-41 in a Population Sample: Comparison of Results and Assessment of Psychometric Properties

The objective of this study was to test the psychometric properties of the QUALEFFO-41, an osteoporosis-specific health-related quality of life (HRQoL) measure, in a population sample. The study involved repeated administration of QUALEFFO-41 and another measure of HRQoL, the SF-36, to a stratified random population sample to test reliability and validity of instrument. The study was set in urban Harrow, Middlesex, UK and rural Cambridgeshire, UK. The participants were 83 males and 88 females aged 65–80+ years. Of the 230 individuals contacted 76.5% participated. The test–retest reliability of most QUALEFFO-41 items was good (Kappa 0.59–0.91) but two items had lower repeatability. Internal consistency was also generally good, but suggestive of some redundancy for three domains. The QUALEFFO-41 domains in general correlated well with SF-36 domains (r= 0.57 to r= 0.87), suggesting good validity. The QUALEFFO-41 has been shown to be a reliable and valid disease-specific HRQoL measure for osteoporosis. In population samples, it can be administered by post, or with a professional available to answer queries. Some specific items perform less well than may be desired and there is evidence of some redundancy, but further investigation is required and there are not yet grounds for textual change. We recommend continued use of this well-validated, reliable instrument.
Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation: results on health-related quality of life and symptom burden. The MANTRA-PAF trial.

The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation (MANTRA-PAF) trial assessed the long-term efficacy of an initial strategy of radiofrequency ablation (RFA) vs. antiarrhythmic drug therapy (AAD) as first-line treatment for patients with PAF. In this substudy, we evaluated the effect of these treatment modalities on the Health-Related Quality of Life (HRQoL) and symptom burden of patients at 12 and 24 months.



During the study period, 294 patients were enrolled in the MANTRA-PAF trial and randomized to receive AAD (N = 148) or RFA (N = 146). Two generic questionnaires were used to assess the HRQoL [Short Form-36 (SF-36) and EuroQol-five dimensions (EQ-5D)], and the Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia (ASTA) was used to evaluate the symptoms appearing during the trial. All comparisons were made on an intention-to-treat basis. Both randomization groups showed significant improvements in assessments with both SF-36 and EQ-5D, at 24 months. Patients randomized to RFA showed significantly greater improvement in four physically related scales of the SF-36. The three most frequently reported symptoms were breathlessness during activity, pronounced tiredness, and worry/anxiety. In both groups, there was a significant reduction in ASTA symptom index and in the severity of seven of the eight symptoms over time.



Both AAD and RFA as first-line treatment resulted in substantial improvement of HRQoL and symptom burden in patients with PAF. Patients randomized to RFA showed greater improvement in physical scales (SF-36) and the EQ-visual analogue scale.
A secondary prevention lipid clinic reaches low-density lipoprotein cholesterol goals more often than usual cardiology care with coronary heart disease.

The objective of this study was to determine whether enrollment in a multidisciplinary secondary prevention lipid clinic (SPLC) for 3 or more years was associated with improved adherence to lipid guidelines as compared with usual care provided by cardiologists.



Patients with documented coronary artery disease (CAD), enrolled in a SPLC, and followed for at least 3 years were identified by the use of a computer database. The comparison group included patients with CAD who received usual care from a cardiologist during the same time period. The percentage of patients achieving low-density lipoprotein cholesterol (LDL-C) goals at enrollment and after at least 3 years of follow-up was determined for both groups. The average total cholesterol, LDL-C, high-density lipoprotein cholesterol (HDL-C), and triglycerides were determined after at least 3 years of follow-up for both groups.



Patients enrolled in the SPLC reached the LDL-C goals more often than usual care cardiology patients (goal <100mg/dL: 81.9% vs. 72.8%, P < .001; optional goal <70 mg/dL: 41.9% vs. 28.6%, P < .001). The patients enrolled in the SPLC had lower average total cholesterol, triglycerides, and LDL-C and greater average HDL-C after 3 years. All the lipid parameters decreased for patients in usual cardiology care, but these changes were not statistically significant.



This multidisciplinary secondary prevention lipid clinic achieved the LDL-C goals (<100mg/dL and optional goal <70 mg/dL) more often than usual cardiology care for patients with CAD after 3 years of lipid management.
Electronic medical records for clinical research: application to the identification of heart failure.

To identify patients with heart failure (HF) by using language contained in the electronic medical record (EMR).



We validated 2 methods of identifying HF through the EMR, which offers transcription of clinical notes within 24 hours or less of the encounter. The first method was natural language processing (NLP) of the EMR text. The second method was predictive modeling based on machine learning, using the text of clinical reports. Natural language processing was compared with both manual record review and billing records. Predictive modeling was compared with manual record review.



Natural language processing identified 2904 HF cases; billing records independently identified 1684 HF cases, 252 (15%) of them not identified by NLP. Review of a random sample of these 252 cases did not identify HF, yielding 100% sensitivity (95% confidence interval [CI] = 86, 100) and 97.8% specificity (95% CI = 97.7, 97.9) for NLP. Manual review confirmed 1107 of the 2904 cases identified by NLP, yielding a positive predictive value (PPV) of 38% (95% CI = 36, 40). Predictive modeling yielded a PPV of 82% (95% CI = 73,93), 56% sensitivity (95% CI = 46, 67), and 96% specificity (95% CI = 94, 99).



The EMR can be used to identify HF via 2 complementary approaches. Natural language processing may be more suitable for studies requiring highest sensitivity, whereas predictive modeling may be more suitable for studies requiring higher PPV.
How to improve clinical practice on involuntary hospital admissions of psychiatric patients: suggestions from the EUNOMIA study.

Number and procedures of involuntary hospital admissions vary in Europe according to the different socio-cultural contexts. The European Commission has funded the EUNOMIA study in 12 European countries in order to develop European recommendations for good clinical practice in involuntary hospital admissions. The recommendations have been developed with the direct and active involvement of national leaders and key professionals, who worked out national recommendations, subsequently summarized into a European document, through the use of specific categories. The need for standardizing the involuntary hospital admission has been highlighted by all centers. In the final recommendations, it has been stressed the need to: providing information to patients about the reasons for hospitalization and its presumable duration; protecting patients' rights during hospitalization; encouraging the involvement of family members; improving the communication between community and hospital teams; organizing meetings, seminars and focus-groups with users; developing training courses for involved professionals on the management of aggressive behaviors, clinical aspects of major mental disorders, the legal and administrative aspects of involuntary hospital admissions, on communication skills. The results showed the huge variation of involuntary hospital admissions in Europe and the importance of developing guidelines on this procedure.
Patterns and utility of routine surveillance in high grade endometrial cancer.

To evaluate surveillance methods and their utility in detecting recurrence of disease in a high grade endometrial cancer population.



We performed a multi-institutional retrospective chart review of women diagnosed with high grade endometrial cancer between the years 2000 and 2011. Surveillance data was abstracted and analyzed. Surveillance method leading to detection of recurrence was identified and compared by stage of disease and site of recurrence.



Two hundred and fifty-four patients met the criteria for inclusion. Vaginal cytology was performed in the majority of early stage patients, but was utilized less in advanced stage patients. CA-125 and CT imaging were used more frequently in advanced stage patients compared to early stage. Thirty-six percent of patients experienced a recurrence and the majority of initial recurrences (76%) had a distant component. Modalities that detected cancer recurrences were: symptoms (56%), physical exam (18%), surveillance CT (15%), CA-125 (10%), and vaginal cytology (1%). All local recurrences were detected by symptoms or physical exam findings. While the majority of loco-regional and distant recurrences (68%) were detected by symptoms or physical exam, 28% were detected by surveillance CT scan or CA 125. One loco-regional recurrence was identified by vaginal cytology but no recurrences with a distant component detected by this modality.



Symptoms and physical examination identify the majority of high grade endometrial cancer recurrences, while vaginal cytology is the least likely surveillance modality to identify a recurrence. The role of CT and CA-125 surveillance outside of a clinical trial needs to be further reviewed.
Occipital nerve stimulation in fibromyalgia: a double-blind placebo-controlled pilot study with a six-month follow-up.

The goal of this study is to evaluate the effectiveness of occipital nerve stimulation (ONS) as a surgical treatment for fibromyalgia in a placebo-controlled design.



Eleven patients were selected based on the American College of Rheumatology-90 criteria and implanted with an occipital nerve trial-lead stimulator. Baseline scores for pain, mood, and fatigue were acquired, and patients were randomized in a ten-week double-blinded crossover design with placebo and effective subsensory threshold stimulation (no paresthesias). After finalizing the trial, nine patients were implanted permanently; evaluation was performed prior to surgery and at six months after surgery for pain, fatigue, and mood of the number of trigger points and overall morbidity.



Significant results were found during the trial for a decrease in pain intensity (39.74%) on visual analogue scale (VAS; p < 0.001) and pain catastrophizing scale (PCS) during effective stimulation. A total of 9/11 patients responded to trial treatment; however, in two patients, this might be a placebo effect, recognizable due to the study design. Six months after permanent implantation, pain intensity remained decreased (44.01%) on VAS (p < 0.05). Besides the VAS, significant changes were noted for PCS, fatigue (modified fatigue impact scale), the number of trigger points, and overall morbidity (fibromyalgia impact questionnaire). There were no serious adverse events.



Our data strongly suggest that ONS is beneficial in the treatment of fibromyalgia. The beneficial effects are stable at six months after permanent implantation. Subsensory threshold stimulation is feasible in designing a placebo-controlled trial.
Incremental value of biomarkers to clinical variables for mortality prediction in acutely decompensated heart failure: the Multinational Observational Cohort on Acute Heart Failure (MOCA) study.

This study aims to evaluate the incremental value of plasma biomarkers to traditional clinical variables for risk stratification of 30-day and one-year mortality in acutely decompensated heart failure (ADHF).



Through an international collaborative network, individual patient data on 5306 patients hospitalized for ADHF were collected. The all-cause mortality rate was 11.7% at 30 days and 32.9% at one year. The clinical prediction model (age, gender, blood pressure on admission, estimated glomerular filtration rate <60 mL/min/1.73 m(2), sodium and hemoglobin levels, and heart rate) had a c-statistic of 0.74 for 30-day mortality and 0.73 for one-year mortality. Several biomarkers measured at presentation improved risk stratification when added to the clinical model. At 30 days, the net reclassification improvement (NRI) was 28.7% for mid-regional adrenomedullin (MR-proADM; p<0.001) and 25.5% for soluble (s)ST2 (p<0.001). At one year, sST2 (NRI 10.3%), MR-proADM (NRI 9.1%), amino-terminal pro-B-type natriuretic peptide (NT-proBNP; NRI 9.1%), mid-regional proatrial natriuretic peptide (MR-proANP; NRI 7.4%), B-type natriuretic peptide (NRI 5.5%) and C-reactive protein (CRP; NRI 5.3%) reclassified patients with ADHF (p<0.05 for all). CRP also markedly improved risk stratification of patients with ADHF as a dual biomarker combination with MR-proADM (NRI 36.8% [p<0.001] for death at 30 days) or with sST2 (NRI 20.3%; [p<0.001] for one-year mortality).



In this study, biomarkers provided incremental value for risk stratification of ADHF patients. Biomarkers such as sST2, MR-proADM, natriuretic peptides and CRP, reflecting different pathophysiologic pathways, add prognostic value to clinical risk factors for predicting both short-term and one-year mortality in ADHF.
Improving parental stress levels among mothers living with HIV: a randomized control group intervention study.

Limited knowledge exists regarding parenting efficacy interventions for mothers living with HIV (MLH). This study evaluated the impact of a supportive group intervention on lowering parenting stress among MLH. Eighty MLH were randomized to a parenting (N=34) or health focused (control) (N=46) group intervention. Pre- and post-intervention stress levels were assessed using the Parental Stress Index-Short Form (PSI/SF). Differences in PSI/SF scores were examined using ANOVA, and predictors of PSI/SF scores were evaluated using multivariable linear regression. Findings indicate that both groups experienced significant decreases in parenting stress from baseline to post-intervention (p=0.0001), with no significant differences between interventions. At baseline, 41% of participants were identified as highly stressed and 30% as clinically stressed, with PSI/SF scores above the 85(th) and 90(th) percentile, respectively. Amongst the highly stressed subpopulation, significant improvements in PSI/SF scores for Parental Distress PSI/SF (p=0.039), Difficult Child PSI/SF (p=0.048), and total PSI/SF (p=0.036) were seen, with greater improvements in the parenting intervention. Among the clinically stressed subpopulation, significant improvements in total post-intervention PSI/SF scores were seen (p=0.049), with greater improvements in the parenting intervention. Results indicate that screening for high levels of stress should be considered in clinical practice to effectively implement stress-reducing interventions among MLH.
Post hoc analysis of the efficacy and safety of desvenlafaxine 50 mg/day in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder.

This post hoc analysis assessed the efficacy of desvenlafaxine 50 mg/day for treating major depressive disorder in perimenopausal versus postmenopausal women enrolled in a 10-week, double-blind, placebo-controlled study.



Perimenopausal and postmenopausal women (40-70 y) diagnosed with major depressive disorder were randomly assigned to receive desvenlafaxine 50 mg/day or placebo. Changes from baseline in the primary efficacy variable (17-item Hamilton Rating Scale for Depression [HAM-D17] score, week 8) and in other secondary efficacy variables (Sheehan Disability Scale and Menopause Rating Scale) were analyzed using analysis of covariance with treatment, region, and baseline in the model. Clinical Global Impressions-Improvement Scale was analyzed with the Cochran-Mantel-Haenszel test. Response and remission rates were evaluated using logistic regression with treatment, region, and baseline HAM-D17 in the model.



Of 426 women (desvenlafaxine, n = 216; placebo, n = 210) included in this analysis, 135 (32%) were perimenopausal and 291 (68%) were postmenopausal at baseline. In both subgroups, improvement from baseline in HAM-D17 scores was significantly greater for desvenlafaxine 50 mg/day than for placebo. Menopause status and time since menopause did not significantly affect HAM-D17 total score. The drug-placebo difference in Sheehan Disability Scale scores was significant in perimenopausal women (-9.3 vs. -5.1, P < 0.001) but not in postmenopausal women (-8.8 vs. -8.1). Menopause Rating Scale and Clinical Global Impressions-Improvement Scale scores were significantly improved with desvenlafaxine in postmenopausal women.



Desvenlafaxine 50 mg/day is effective in treating depression in both perimenopausal and postmenopausal women. Placebo response on measures of functional impairment is lower in perimenopausal women than in postmenopausal women, resulting in a greater apparent treatment benefit with desvenlafaxine among perimenopausal women.
Genetic and environmental influences on body fat distribution, fasting insulin levels and CVD: are the influences shared?

Central body fat distribution has been shown to be related to hyperinsulinemia, insulin resistance, hypertriglyceridemia, and atherosclerosis to a greater degree than general obesity. There are known to be both genetic and environmental effects on all components of this clustering. Whether these genetic effects are due to one set of genes in common to the components or whether genetic influences on insulin resistance and/or general/abdominal fatness 'turn on' other genes that affect other components of the syndrome is not clear. We analyzed data from the Swedish Adoption/Twin Study of Aging (60% female; monozygotic = 116, dizygotic = 202; average age 65 years) to determine whether there were genetic and/or environmental factors shared among general body fat distribution, abdominal body fat distribution, fasting insulin levels and cardiovascular disease. We found additive genetic effects in males to be significantly different from those in females with genetic effects accounting for variance in waist-hip ratio (males = 28%; females = 49%), body mass index (males = 58%; females = 73%), fasting insulin levels (FI) (males = 27%; females = 49%), and cardiovascular disease (CVD) (males = 18%; females = 37%). There were also shared genetic and environmental effects among all the variables except CVD, but a majority of the genetic variance for these measures was trait specific.
Socioeconomic status and social support following illicit drug use: causal pathways or common liability?

The negative social attributes associated with drug use and abuse/dependence may arise as a result of shared genetic or environmental factors rather than through causal pathways. To evaluate this possibility, structured interviews were conducted for 3969 male and female twins from the Mid-Atlantic Twin Registry and evaluations of their socioeconomic status (SES), social interactions, and use of drugs were obtained. Drug involvement was categorized as never used, tried, or met criteria for abuse or dependence. A co-twin control design was implemented using hierarchical linear modeling to assess whether twins who used drugs experienced lower SES and social support than non-using co-twins. Poorer social functioning in the drug-exposed twin is consistent with a causal relationship, while similar functioning in the drug exposed versus naive twins imply shared genetic or common environmental factors. Use of drugs was not significantly related to any SES measures. However, education and job status appear to share genetic influences with drug abuse/dependence. Lower income was not related to abuse/dependence of drugs. Negative interactions with friends and relatives share genetic factors with use of drugs, but the escalation from trying drugs to abusing them appears to generate discord between the abuser and friends and relatives in a causal fashion. These results indicate that presumptive causal influences of drug abuse/dependence on low SES may actually be mediated by shared genes. Drug use and social discord also appear to have shared genetic factors, but increased levels of drug involvement seem to causally influence social interactions.
Rapid oral transmucosal absorption of sumatriptan, and pharmacodynamics in acute migraine.

(1) To determine whether sumatriptan can be absorbed across the oral mucosa, and, if so; then (2) to describe its pharmacokinetics; and (3) to investigate whether there are pharmacodynamic correlates of such pharmacokinetics in patients experiencing migraine attacks.



Two clinical trials. The first, in normal volunteers, compared the pharmacokinetic performance of a lingual spray (LS) formulation of sumatriptan (2 dose sizes, one of which in both the fed and fasted state) with an orthodox 50-mg sumatriptan tablet. The second clinical trial, in a patient population enriched by documenting suboptimal response to an initial 50-mg sumatriptan tablet, was a multiple-attack, crossover, fixed dose-order, open-label comparison of sumatriptan administered by LS (up to 3 different dose sizes) and a 100-mg sumatriptan tablet.



The LS formulations resulted in double-peaked time-plasma concentration curves that are consistent with absorption of sumatriptan across the oral mucosa. The first T(max) was usually about 10-15 minutes. In the enriched patient population, this corresponded with evidence of earlier efficacy for the LS in comparison with a 50-mg tablet; the lower dose size for the former was consistent with oral mucosal drug absorption, and evasion of first-pass metabolism.



The initial pharmacokinetics of LS approximate to those of a subcutaneous injection, albeit some fraction of these doses is also swallowed. These pharmacokinetics correspond with earlier effectiveness of LS in comparison with a 50-mg sumatriptan tablet, and at lower dose, in an enriched, relevant patient population. These initial studies support further development of this innovative formulation of sumatriptan and this new route of administration.