nils-herrmann/clean_scirepeval huggingface dataset:
Development of a questionnaire (EORTC module) to measure quality of life in patients with cholangiocarcinoma and gallbladder cancer, the EORTC QLQ-BIL21

Quality of life measurement in cholangiocarcinoma and gallbladder cancer involves the assessment of patient-reported issues related to the symptoms, disease and treatment of these tumours. This study describes the development of the disease-specific quality of life (QoL) questionnaire for patients with cholangiocarcinoma and gallbladder cancer to supplement the European Organization for Research and Treatment of Cancer (EORTC)-QLQ C30 core cancer questionnaire.Phases 1–3 of the guidelines for module development published by the EORTC were followed, with adaptations for incorporation of questions from existing modules.A total of 47 QoL issues (questions) were identified; 44 questions from the two related validated questionnaires, the EORTC QLQ-PAN26 (pancreatic module) and the EORTC QLQ-LMC21 (liver metastases module), two from the Functional Assessment of Cancer Therapy hepatobiliary module questionnaire in the literature search and one from healthcare professional interviews. Following phase 1 and 2 interviews with patients (n=101) and health care professionals (n=6), a 23-question provisional questionnaire was formulated. There were five questions from PAN26, 15 from LMC21 and three extra questions. In phase 3, the provisional item list was pre-tested in 52 patients in four languages and this resulted in a 21-item module.This is the only disease-specific QoL questionnaire for patients with cholangiocarcinoma and gallbladder cancer, and initial assessments show it to be accurate and acceptable to patients in reflecting QoL in these diseases.
Pleiotropic effects of angiotensin-converting enzyme inhibitors in normotensive patients with coronary artery disease.

Angiotensin-converting enzyme inhibitors proved to be effective in the primary and secondary prevention of cardiovascular diseases. Clinical effectiveness of this group of agents may largely depend on their pleiotropic effects. The purpose of this study was to compare the effects of plasma- and tissue-type angiotensin-converting enzyme inhibitors on blood pressure and on systemic inflammation, hemostasis and oxidative functions in normotensive patients with stable coronary artery disease. Ninety patients with stable coronary artery disease enrolled into the study were randomly divided into three different groups, simultaneously treated with enalapril (20 mg/d, n = 30), perindopril (4 mg/d, n = 30) or placebo (n = 30). Plasma lipid profile and the levels of oxidized low density lipoproteins (LDLs), monocyte chemoattractant protein (MCP)-1, interleukin-10, C-reactive protein (CRP), fibrinogen and plasminogen activator inhibitor (PAI)-1 were determined at the beginning of the study and after 30 and 90 days of treatment. Seventy-six patients completed the trial. Neither enalapril nor perindopril affected blood pressure or plasma lipids. Perindopril significantly reduced plasma levels of oxidized LDLs, CRP, MCP-1, fibrinogen and PAI-1, and increased interleukin-10. The effect of enalapril on these markers of systemic inflammation, hemostasis and oxidative functions was much less pronounced. The results showed that enalapril and perindopril were devoid of a blood pressure-lowering effect in normotensive patients with stable coronary artery disease. Perindopril was superior to enalapril in exhibiting antioxidant, antithrombotic and profibrinolytic activities. The treatment-induced changes in the balance between pro- and antiinflammatory cytokines and in hemostasis may contribute to the clinical effectiveness of tissue angiotensin-converting enzyme inhibitors in the therapy of atherosclerosis-related disorders.
International validation of the Chinese University Prognostic Index for staging of hepatocellular carcinoma: a joint United Kingdom and Hong Kong study

The outcome of hepatocellular carcinoma (HCC) patients significantly differs between western and eastern population centers. Our group previously developed and validated the Chinese University Prognostic Index (CUPI) for the prognostication of HCC among the Asian HCC patient population. In the current study, we aimed to validate the CUPI using an international cohort of patients with HCC and to compare the CUPI to two widely used staging systems, the Barcelona Clinic Liver Cancer (BCLC) classification and the Cancer of the Liver Italian Program (CLIP). To accomplish this goal, two cohorts of patients were enrolled in the United Kingdom (UK; n = 567; 2006-2011) and Hong Kong (HK; n = 517; 2007-2012). The baseline clinical data were recorded. The performances of the CUPI, BCLC, and CLIP were compared in terms of a concordance index (C-index) and were evaluated in subgroups of patients according to treatment intent. The results revealed that the median follow-up durations of the UK and HK cohorts were 27.9 and 29.8 months, respectively. The median overall survival of the UK and HK cohorts were 22.9 and 8.6 months, respectively. The CUPI stratified the patients in both cohorts into three risk subgroups corresponding to distinct outcomes. The median overall survival of the CUPI low-, intermediate-, and high-risk subgroups were 3.15, 1.24, and 0.29 years, respectively, in the UK cohort and were 2.07, 0.32, and 0.10 years, respectively, in the HK cohort. For the patients who underwent curative treatment, the prognostic performance did not differ between the three staging systems, and all were suboptimal. For those who underwent palliative treatment, the CUPI displayed the highest C-index, indicating that this staging system was the most informative for both cohorts. In conclusion, the CUPI is applicable to both western and eastern HCC patient populations. The performances of the three staging systems differed according to treatment intent, and the CUPI was demonstrated to be optimal for those undergoing palliative treatment. A more precise staging system for early-stage disease patients is required.
Bone mineral density in Klinefelter syndrome is reduced and primarily determined by muscle strength and resorptive markers, but not directly by testosterone

Klinefelter syndrome (KS) patients have lower bone mineral density (BMD) at the spine, hip and forearm compared to healthy subjects, but frank osteoporosis is not common. Muscle strength and bone markers predicted BMD but KS itself and serum testosterone did not. Low vitamin D and high PTH were frequent among KS. The long-term consequence of KS on bone health is not well described. The objective of this study is to investigate the regional BMD and its determinants in KS. This is a cross-sectional study. BMD at the spine, hip and forearm are measured by DXA and correlated to biochemical markers of bone turnover, vitamin D metabolites, PTH, sex hormones, growth factors as well as muscle strength and anthropometric measures. The setting is at a university clinical research centre. The study involves 70 adult KS patients and 71 age-matched healthy subjects. In KS, BMD was universally lowered in all regions. Markers of bone formation or bone resorption were not altered in KS, but 25-OH-Dvitamin was lower (55 vs. 82 nmol/L, p < 0.0001) than in healthy subjects. Significantly more KS patients had low BMD (Z-scores below −2) at the forearm (15 KS vs. two healthy subjects, p = 0.001) but not at the spine or hip. Muscle strength (bicep and quadriceps) was lower among KS patients. Multivariate analysis revealed that muscle strength, treatment with testosterone (ever/never), age at diagnosis, SHBG, bone-specific alkaline phosphatase and 1CTP were all independent predictors of BMD, but androgens was not. KS patients had lower BMD at the spine, hip and forearm compared to age-matched healthy subjects, but frank osteoporosis was not common. Muscle strength, previous history of testosterone treatment, age at diagnosis and bone markers were predictors of BMD, but testosterone was not. Signs of secondary hyperparathyroidism were present among KS. Dietary intake of vitamin D or sun exposure may be lower in KS patients.
Group patient visits for Parkinson disease: a randomized feasibility trial.

Group patient visits are medical appointments shared among patients with a common medical condition. This care delivery method has demonstrated benefits for individuals with chronic conditions but has not been evaluated for Parkinson disease (PD).



We conducted a 12-month, randomized trial of group patient visits vs usual (one-on-one) care for patients with PD. Visits were led by one of 3 study physicians, included patients and caregivers, and lasted approximately 90 minutes. Those receiving group visits had 4 sessions over 12 months. The primary outcome measure was feasibility as measured by the ability to recruit participants and by the proportion of participants who completed the study. The primary efficacy outcome was quality of life as measured by the PD Questionnaire-39.



Thirty patients and 27 caregivers enrolled in the study. Thirteen of the 15 patients randomized to group patient visits and 14 of the 15 randomized to usual care completed the study. Quality of life measured 12 months after baseline between the 2 groups was not different (25.9 points for group patient visits vs 26.0 points for usual care; p = 0.99).



Group patient visits may be a feasible means of providing care to individuals with PD and may offer an alternative or complementary method of care delivery for some patients and physicians.



This study provides Class II evidence that group patient visits did not improve quality of life for individuals with PD over a 1-year period.
Closed-Loop Basal Insulin Delivery Over 36 Hours in Adolescents With Type 1 Diabetes

We evaluated the safety and efficacy of closed-loop basal insulin delivery during sleep and after regular meals and unannounced periods of exercise.



Twelve adolescents with type 1 diabetes (five males; mean age 15.0 [SD 1.4] years; HbA1c 7.9 [0.7]%; BMI 21.4 [2.6] kg/m(2)) were studied at a clinical research facility on two occasions and received, in random order, either closed-loop basal insulin delivery or conventional pump therapy for 36 h. During closed-loop insulin delivery, pump basal rates were adjusted every 15 min according to a model predictive control algorithm informed by subcutaneous sensor glucose levels. During control visits, subjects' standard infusion rates were applied. Prandial insulin boluses were given before main meals (50-80 g carbohydrates) but not before snacks (15-30 g carbohydrates). Subjects undertook moderate-intensity exercise, not announced to the algorithm, on a stationary bicycle at a 140 bpm heart rate in the morning (40 min) and afternoon (20 min). Primary outcome was time when plasma glucose was in the target range (71-180 mg/dL).



Closed-loop basal insulin delivery increased percentage time when glucose was in the target range (median 84% [interquartile range 78-88%] vs. 49% [26-79%], P = 0.02) and reduced mean plasma glucose levels (128 [19] vs. 165 [55] mg/dL, P = 0.02). Plasma glucose levels were in the target range 100% of the time on 17 of 24 nights during closed-loop insulin delivery. Hypoglycemia occurred on 10 occasions during control visits and 9 occasions during closed-loop delivery (5 episodes were exercise related, and 4 occurred within 2.5 h of prandial bolus).



Day-and-night closed-loop basal insulin delivery can improve glucose control in adolescents. However, unannounced moderate-intensity exercise and excessive prandial boluses pose challenges to hypoglycemia-free closed-loop basal insulin delivery.
Combination therapy with nifedipine GITS 60 mg: subanalysis of a prospective, 12-week observational study (AdADOSE)

AdADOSE was a 12-week, international, observational study conducted in the Middle East and Russia where patients received nifedipine gastrointestinal therapeutic system (GITS) at a daily dose of 30, 60, or 90 mg as part of an antihypertensive combination therapy. This subgroup analysis of the AdADOSE study assesses the efficacy and tolerability of nifedipine GITS combination therapy when used specifically at the 60-mg strength.



Patients with hypertension who received a daily nifedipine GITS dose of 60 mg, either at constant dose (n = 686) or up-titrated from 30 mg (n = 392), were analyzed. Target blood pressure (BP) was <140/90 mmHg (or <130/80 mmHg for those at high/very high cardiovascular risk).



Following nifedipine GITS combination therapy, target BP was achieved by 33.7% patients in the 60 mg group (previously untreated, 42.5%; previously treated, 32.0%) and 32.4% patients in the 30-60 mg group (previously untreated, 45.2%; previously treated, 30.7%). Mean systolic BP/diastolic BP changes were -40.3/-20.7 mmHg and -35.6/-18.5 mmHg, respectively, and were similar regardless of previous antihypertensive treatment or the number of concomitant diseases. Incidences of drug-related adverse events (AEs) were low (3.2%, 60 mg; 2.0%, 30-60 mg group), few patients discontinued because of AEs (0.6% and 1.0%, respectively), and there were no serious AEs.



Combination therapy with nifedipine GITS 60 mg in a real-life observational setting was effective and well tolerated in hypertensive patients, with low rates of treatment-related AEs.
Treatment of poststroke pain by epidural motor cortex stimulation with a new octopolar lead.

Chronic, drug-resistant neuropathic pain can be treated by surgically implanted motor cortex stimulation (MCS). The leads used for MCS have not been specifically designed for this application.



To study the value of a new 8-contact lead for MCS therapy in a series of 6 patients with refractory central poststroke pain.



The study comprised a 1-month randomized phase, starting 1 month after implantation, during which the neurostimulator was switched on in one-half of the patients or remained off in the other half, followed by an open phase of 10 months, during which the stimulator was switched on in all patients. Clinical assessment was performed at baseline and 1, 2, 3, 6, and 12 months after implantation with the following scales: Visual Analog Scale, Verbal Rating Scale, Brief Pain Inventory, McGill Pain Questionnaire, Sickness Impact Profile, and Medication Quantification Scale.



In the randomized phase, clinical scores were found to be globally reduced in the on- vs off-stimulation condition. In the open follow-up phase, all clinical scores improved significantly over time. The ratio between affective and sensory McGill Pain Questionnaire subscores decreased, suggesting a preferential effect of MCS on the affective component of pain. Compared with preoperative baseline, 2 patients were totally relieved of central poststroke pain, 3 patients were very much relieved, and 1 patient remained unchanged at the final examination.



A good clinical outcome was observed in all patients except 1, suggesting that this new octopolar lead could be used for MCS therapy to treat refractory central poststroke pain.
“A year-long, fortnightly, observational survey in three European countries of patients with respiratory allergies induced by house dust mites: Methodology, demographics and clinical characteristics”

House dust mite (HDM) allergens constitute the leading trigger for the symptoms of persistent respiratory allergies (such as allergic rhinitis and asthma). However, the fluctuating, pernicious nature of the symptoms has given rise to a perception that HDM-induced respiratory allergy is not a "real" disease.



In order to assess the self-reported disease profile and behaviour of adult patients with a self-reported history of severe, poorly controlled, physician-diagnosed HDM respiratory allergy, we performed an observational, international, multicentre survey in three European countries (France, Italy and Spain). Participants were included in the survey if they passed a short Internet-based screening questionnaire. Following completion of a detailed post-inclusion questionnaire, 28 fortnightly telephone interviews were used to gather extensive data on the participants' symptom prevalence and intensity, medical consultations, disease burden, quality of life, and medication use from late May 2012 to early July 2013.



Twenty-two thousand nine hundred ninety five individuals completed the Internet screening questionnaire and 339 respondents (67 % female) met all the inclusion criteria. 313 of the 339 (92 %) completed the post-inclusion questionnaire (n = 114 in Italy, 92 in France and 107 in Spain). The median time since the first symptoms of HDM allergy was over 13 years in all three countries. The response rate for the fortnightly interviews averaged 75 % (range: 29 to 97 %). The reported fortnightly prevalence of nasal and ocular symptoms peaked in the autumn (September to November) and spring (March to May). These peaks in prevalence coincided with increased reports of symptom worsening and higher physician consultation rates. In participants not allergic to pollen, the autumn and spring peaks were accompanied by a third peak in late December 2012. Very few participants reported that their symptoms had never improved (4 %) or never worsened (11 %) during the survey period.



In a survey in France, Italy and Spain, patients with severe HDM-induced respiratory allergies experienced a complex set of changing, troublesome symptoms throughout the year, with peaks in spring, autumn and (to a lesser extent) mid-winter.
Genetic influences on alcohol-related hangover.

To quantify the relative contributions of genetic and environmental factors to alcohol hangover.



Biometric models were used to partition the variance in hangover phenotypes.



A community-based sample of Australian twins.



Members of the Australian Twin Registry, Cohort II who reported consuming alcohol in the past year when surveyed in 2004-07 (n = 4496).



Telephone interviews assessed participants' frequency of drinking to intoxication and frequency of hangover the day after drinking. Analyses examined three phenotypes: hangover frequency, hangover susceptibility (i.e. residual variance in hangover frequency after accounting for intoxication frequency) and hangover resistance (a dichotomous variable defined as having been intoxicated at least once in the past year with no reported hangovers).



Genetic factors accounted for 45% [95% confidence interval (CI) = 37-53%] and 40% (95% CI = 33-48%) of the variation in hangover frequency in men and women, respectively. Most of the genetic variation in hangover frequency overlapped with genetic contributions to intoxication frequency. Genetic influences accounted for 24% (95% CI = 14-35%) and 16% (95% CI = 8-25%) of the residual hangover susceptibility variance in men and women, respectively. Forty-three per cent (95% CI = 22-63%) of the variation in hangover resistance was explained by genetic influences, with no evidence for significant sex differences. There was no evidence for shared environmental influences for any of the hangover phenotypes.



Individual differences in the propensity to experience a hangover and of being resistant to hangover at a given level of alcohol use are genetically influenced.
Comparison of two self-rating instruments for medication adherence assessment in hypertension revealed insufficient psychometric properties.

In cases of insufficiently controlled blood pressure, it is important for practitioners to distinguish between "nonadherence" and "nonresponse" to antihypertensive drug treatment. A reliable and valid adherence measurement based on the patient's self-report may be helpful in daily practice.



In a primary care sample with 353 hypertensive patients, we applied two self-rating instruments to assess medication adherence (the "Hill-Bone Compliance to High Blood Pressure Therapy Scale" and Morisky's "Self-Reported Measure of Medication Adherence") and compared their psychometric properties.



Both scales showed low acceptability and insufficiency to moderate internal consistency (Cronbach's alpha=0.25 and 0.73, respectively). Their convergent validity as indexed by kappa=0.39 could be judged as "fair" at best. Testing the power to predict blood pressure >140/90mmHg, both scales showed an accuracy of 57% and 62%, respectively. The positive likelihood, that is, the increase in likelihood of high blood pressure in cases of nonadherence was 1.00 and 1.32, respectively.



The use of both scales cannot be recommended. They showed considerable floor effects, and their ability to identify medication adherence was inconsistent for nearly every third patient. The power of both scales to predict uncontrolled blood pressure was essentially a chance. The underlying conceptual framework of medication adherence therefore needs to be rethought.
Description and design considerations of a randomized clinical trial investigating the effect of a multidisciplinary cognitive-behavioural intervention for patients undergoing lumbar spinal fusion surgery

The ideal rehabilitation strategy following lumbar spinal fusion surgery has not yet been established. This paper is a study protocol, describing the rationale behind and the details of a cognitive-behavioural rehabilitation intervention for lumbar spinal fusion patients based on the best available evidence. Predictors of poor outcome following spine surgery have been identified to provide targets for the intervention, and the components of the intervention were structured in accordance with the cognitive-behavioural model. The study aims to compare the clinical and economical effectiveness of a cognitive-behavioural rehabilitation strategy to that of usual care for patients undergoing lumbar spinal fusion surgery.



The study is a randomized clinical trial including 96 patients scheduled for lumbar spinal fusion surgery due to degenerative disease or spondylolisthesis. Patients were recruited in the period October 2011 to July 2013, and the follow-up period is one year from date of surgery. Patients are allocated on a 1:2 ratio (control: intervention) to either treatment as usual (control group), which implies surgery and the standard postoperative rehabilitation, or in addition to this, a patient education focusing on pain behaviour and pain coping (intervention group). It takes place in a hospital setting, and consists of six group-based sessions, managed by a multidisciplinary team of health professionals.The primary outcomes are disability (Oswestry Disability Index) and sick leave, while secondary outcomes include coping (Coping Strategies Questionnaire), fear-avoidance belief (Fear Avoidance Belief Questionnaire), pain (, mobility during hospitalization (Cumulated Ambulation Score), generic health-related quality of life (EQ-5D) and resource use. Outcomes are measured using self report questionnaires, medical records and national registers.



It is expected that the intervention can provide better functional outcome, less pain and earlier return to work after lumbar spinal fusion surgery. By combining knowledge and evidence from different knowledge areas, the project aims to provide new knowledge that can create greater consistency in patient treatment. We expect that the results can make a significant contribution to development of guidelines for good rehabilitation of patients undergoing lumbar spinal fusion.