nils-herrmann/clean_scirepeval huggingface dataset:
A statistical comparison of prognostic index systems for brain metastases after stereotactic radiosurgery or fractionated stereotactic radiation therapy.

Prognostic indices are commonly used in the context of brain metastases radiotherapy to guide patient decision-making and clinical trial stratification. The purpose of this investigation was to compare nine published brain metastases prognostic indices using traditional and novel statistical comparison metrics.



A retrospective review was carried out on two institutional databases of 501 patients diagnosed with brain metastatic disease, who received either stereotactic radiosurgery (n = 381) or fractionated stereotactic radiation therapy (n = 120) between 2002 and 2011. Descriptive statistics were generated for patient, tumour and treatment factors, as well as prognostic indices distribution. To identify predictors of overall survival, Kaplan-Meier estimates and multivariable Cox proportional hazard analyses were carried out. Prognostic indices were compared with each other using novel metrics, including: net reclassification improvement (NRI) index, integrated discrimination improvement (IDI) index and decision curve analysis (DCA).



Multivariable Cox modelling confirmed the importance of all individual prognostic indices component factors except for 'active primary cancer' tumour status. When traditional and novel comparative metrics were incorporated, the available published prognostic indices were found to have important general classification benefits as follows: Radiation Therapy Oncology Group recursive partitioning analysis (RTOG RPA; NRI and DCA), Rades et al. first index (RADES I; IDI and DCA), Golden grading system (GGS; IDI and DCA) and Rotterdam index (RDAM; major misclassification rate and NRI). The graded prognostic assessment system had the smallest misclassification rate (5%) in terms of high-risk (i.e. poor prognosis) classification.



Summarising the various comparative approaches used in this report, we found that the RTOG RPA, GGS, RADES I and RDAM systems were superior in more than one metric studied. Of these, only the RTOG RPA has been extensively validated using large datasets and clinically utilised both at the patient level and in clinical trials.
Roux-en-Y gastric bypass vs sleeve gastrectomy for obese patients with type 2 diabetes: a randomised trial

Bariatric surgery is gaining acceptance as a ‘metabolic surgical intervention’ for patients with type 2 diabetes. The optimal form of surgery and the mechanism of action of these procedures are much debated. We compared two bariatric procedures for obese patients with type 2 diabetes and evaluated their effects on HbA1c and glucose tolerance. We performed a parallel un-blinded randomised trial of Roux-en-Y gastric bypass (RYGB) vs sleeve gastrectomy (SG) in 41 obese patients with type 2 diabetes, who were bariatric surgery candidates attending the obesity clinic. HbA1c, body composition and glucose tolerance were evaluated at baseline, and at 3 and 12 months. Of the 41 patients, 37 completed the follow-up (19 RYGB, 18 SG). Both groups had similar baseline anthropometric and biochemical measures, and showed comparable weight loss and fat:fat-free mass ratio changes at 12 months. A similar normalisation of HbA1c levels was observed as early as 3 months post-surgery (6.37 ± 0.71% vs 6.23 ± 0.69% for RYGB vs SG respectively, p < 0.001 in both groups for baseline vs follow-up). In this study, RYGB did not have a superior effect in comparison to SG with regard to HbA1c levels or weight loss during 12 months of follow-up. ClinicalTrials.gov NCT00667706 This work was supported by grant no. 3-000-8480 from the Israel Ministry of Health Chief Scientist, the Stephen Morse Diabetes Research Foundation and by Johnson & Johnson.
A pilot study to test the effects of art-making classes for family caregivers of patients with cancer.

To test the effects of an art-making class (AMC) on reducing anxiety and stress among family caregivers of patients with cancer.



A pretest and post-test quasi-experimental design.



A residential care facility near tertiary treatment centers in the southeastern United States.


SAMPLE
The convenience sample of 69 family caregivers was aged 18-81 years (X = 48 years) and predominantly Catholic. Most had at least a high school education. Two-thirds were daughters, wives, or mothers of patients with cancer.



Participants completed a demographic data survey and a Beck Anxiety Inventory (BAI). Researchers collected a saliva sample from each participant to measure salivary cortisol, which indicates stress levels. Following pretesting, a two-hour AMC was delivered. Post-tests included a repeat BAI and a second saliva sample.



Anxiety and stress.



Anxiety was significantly reduced after AMC. Stress was reduced.



The AMC appeared to reduce anxiety and stress. The addition of a control group and replication with larger numbers are suggested. The physiologic cortisol measure corroborated BAI findings but was difficult to obtain from some cultural groups and was expensive to analyze.



Family caregivers may benefit from participation in art-making interventions. Nurses should continue to investigate the use of creative approaches to promote holistic care.
Heart failure: tools for nursing and medical treatment.

To validate a structured interview designed to evaluate the healthcare and information needs of patients with heart failure (HF), who were also characterized by means of the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the 36-item Short-Form Health Survey (SF-36).



Forty-five in- and outpatients with HF were administered a structured interview concerning their information and healthcare needs (together with the KCCQ and SF-36) with the aim of investigating the effects of healthcare models on their quality of life (QoL). Twenty-one patients were also involved in a one-week test-retest validity study carried out in order to verify reproducibility and stability by means of concordance and K statistics.



The reproducibility of the structured interview was good or very good for all items, with a mean Kw of 0.59; the clarity and acceptability of most of the questions were good. Positive judgements of hospital care inversely related to the patients' New York Heart Association class. The subjects about which the patients sought greater information were diet, sleep, therapies and physical exercise, with cardiologists and general practitioners (GPs) being more involved than nurses. The most frequently discussed subject was diagnostic examinations. The questionnaire scores of our patients were generally lower than those reported in the literature, possibly because of their advanced age. However, it is difficult to believe that the quality of care was extraneous to their generally worse health-related QoL.



Our HF patients experienced a 'basic' healthcare model (hospitals, GPs, cardiologists) and judged them acceptable. Their ability to think critically about care was increasingly compromised as HF progressed and their health-related QoL decreased.
A Nonrandomized, Open-Label, Multicenter, Phase 4 Pilot Study on the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (RESPOND).

The aim of this study was to assess the effectiveness and safety of ILUVIEN® in patients with chronic diabetic macular edema (DME) who were insufficiently responsive to prior therapies.



This is a prospective, nonrandomized, multicenter, open-label, phase 4 pilot study assessing the effectiveness and safety of ILUVIEN® involving 12 patients insufficiently responsive to available therapies. Assessments were performed at screening, baseline, week 1, and months 1, 3, 6, 9, and 12. Demographics, medical/ophthalmic history, prior laser, anti-VEGF, and steroid treatments, and lab tests were recorded at screening. A complete ophthalmic examination and SD-OCT were performed at screening and at all follow-up visits.



The patients showed improvements in best-corrected visual acuity (+3.7 letters), with greater improvement among pseudophakic patients (+6.8 letters) compared with phakic patients (-2.5 letters) 12 months after ILUVIEN®. The mean central subfield thickness decrease from baseline to month 12 was statistically significant, with a rapid reduction in the first week. Regarding safety, only 2 patients showed an intraocular pressure (IOP) increase over 25 mm Hg during the study, and the rise in IOP was well managed with eye drops only.



This prospective and pilot study suggests that ILUVIEN® is safe and may be considered effective for chronic DME patients insufficiently responsive to other available therapies as it showed a rapid and sustained improvement of macular edema obtained after treatment with ILUVIEN®.
Reasons for Switching Antihypertensive Medication in General Practice

To improve blood pressure (BP) control of their patients, physicians either adjust or switch antihypertensive medication. Currently, there is only limited information available on why physicians decide to switch antihypertensive medications. A questionnaire-based survey was performed between November 2011 and March 2012 in the Czech Republic. General practitioners were asked to fill in questionnaires about their hypertensive patients whose antihypertensive medication they were planning to change. These questionnaires recorded data about patient demographic information, cardiovascular risk factors, BP values, and reasons for switching antihypertensive medication. Two hundred eight-six general practitioners surveyed a total of 4341 hypertensive patients. The mean age of the patients was 59.8 years, 68.9% of patients were overweight or obese. Uncontrolled office systolic and diastolic BP >140/90 mm Hg was present in 89.6% and 81.5% of patients, respectively, despite the fact that 49.4% of patients used a combination of 2 or more antihypertensive drugs. The most common reasons for switching medication were insufficient BP control (73.7%), followed by aiming for a better 24-hour effect (38.4%) and increased cardiovascular risk of the patients (37.7%). The major reason for switching antihypertensive treatment in general practice was insufficient BP control. Switching medication because of adverse drug effects is less frequent than reported a decade ago.
Sensitive tenofovir resistance screening of HIV-1 from the genital and blood compartments of women with breakthrough infections in the CAPRISA 004 tenofovir gel trial.

The Centre for the AIDS Programme of Research in South Africa 004 (CAPRISA 004) study demonstrated that vaginally applied tenofovir gel is a promising intervention for protecting women from sexually acquiring human immunodeficiency virus (HIV). However, the potential for emergence of tenofovir resistance remains a concern in women who seroconvert while using the gel despite the lack of plasma virus resistance as assessed by population sequencing during the trial. We applied highly sensitive polymerase chain reaction-based assays to screen for tenofovir resistance in plasma and vaginal swab specimens. The absence of mutation detection suggested little immediate risk of tenofovir-resistant HIV-1 emergence and forward transmission in settings in which gel users are closely monitored for HIV seroconversion.
Evaluation eines Kommunikationstrainings für Altenpfleger in der stationären Betreuung demenzkranker Menschen (Tandem im Pflegeheim)

Mit dem Ziel, die berufliche Beanspruchung von Altenpflegern zu reduzieren und gleichzeitig die Lebensqualität demenzkranker Bewohner zu steigern, wurde ein Training für Altenpfleger zur Kommunikation in der stationären Dementenbetreuung entwickelt, durchgeführt und evaluiert. Schwerpunkte des Trainings lagen auf Problemen und Strategien in der Kommunikation mit demenzkranken Menschen sowie mit Kollegen. Die Wirksamkeit der Intervention wurde in einer kontrollierten Trainingsstudie mit Wartekontrollgruppendesign und Prozesserhebung überprüft, an der 53 Altenpflegekräfte teilnahmen, die in täglichem Kontakt mit demenzkranken Bewohnern standen. In Prä-Post- und prozessualen Analysen konnte nachgewiesen werden, dass das Training die soziale Kompetenz der Pfleger steigert und deren psychische Beanspruchung reduziert sowie die Lebensqualität der betreuten demenzkranken Bewohner steigert. Die Ergebnisse der Studie weisen darauf hin, dass das Training eine effektive Möglichkeit zur Verbesserung der Situation in der stationären Dementenbetreuung darstellt. Damit die Intervention breit einsetzbar ist, wird derzeit ein Multiplikatorenprogramm entwickelt, das in einer Folgestudie durchgeführt und evaluiert werden soll. The purpose of this study was to develop and evaluate a skill training aimed at increasing the social competence of caregivers of nursing home residents suffering from dementia. Herewith, the professional burden and occupational stress of the caregivers should be reduced and the quality of life of dementia patients should be increased. The contents of the training focused on problems and strategies in the communication with dementia patients and the communication with colleagues. The effectiveness of the intervention was tested in a controlled training study using a multiple control group design and process measurement. The participants of the trainings were 53 nursing home professionals, who were in daily contact with residents suffering from dementia. The results of the study verify effects for all relevant variables. The “social competence” of the caregivers increased and their “work stress” decreased while the “quality of life of dementia patients” increased. Therefore it can be concluded that training the social competence of nursing home professionals is a method to indirectly reduce their work stress and support dementia patients. The results of research in this program underline very clearly that the developed training is an effective option to improve the situation of dementia care in nursing homes. To make the intervention widely applicable we are currently developing a “multiplier program“ in a follow-up project.
Multi‐institutional retrospective study of mucoepidermoid carcinoma treated with carbon‐ion radiotherapy

This study aimed to evaluate the clinical outcomes of patients with mucoepidermoid carcinomas in the head and neck treated with carbon-ion radiotherapy. Data from 26 patients who underwent carbon-ion radiotherapy in four facilities were analyzed in this multi-institutional retrospective study: the Japan Carbon-ion Radiation Oncology Study Group. The median follow-up time was 34 months. One patient experienced local recurrence, and the 3-year local control rate was 95%. One patient developed lymph node recurrence and five developed distant metastases. The 3-year progression-free survival rate was 73%. Five patients died, two of mucoepidermoid carcinoma and three of intercurrent disease. The 3-year overall survival rate was 89%. Acute mucositis and dermatitis of grade 3 or higher were experienced by 19% and 8% of patients, respectively; these improved with conservative therapy. Late mucositis and osteonecrosis of jaw were observed in 12% and 23% of patients, respectively. The 3-year cumulative rate of any late adverse event of grade 3 or higher was 14%. None of the patients died of the acute or late adverse events. Carbon-ion radiotherapy was efficacious and safe for treating mucoepidermoid carcinoma in this multi-institutional retrospective study (registration no. UMIN000024473). We are currently undertaking a prospective multicenter study.
Direct colposcopic vision used with the LLETZ procedure for optimal treatment of CIN: results of joint cohort studies

To assess the value of direct colposcopic vision (DCV) for optimizing large loop excision of the transformation zone (LLETZ) for the treatment of cervical intraepithelial neoplasia (CIN). Data from 648 patients who underwent excisional procedures for CIN and were included in two previously published cohort studies were retrospectively reviewed. Women who had a LLETZ were included for analysis (n = 436). Margin status, surgical specimen dimensions and volume were analysed according to the use of colposcopy during procedure. Compared to LLETZ guided by previous colposcopy report only, and to LLETZ performed immediately after colposcopy, DCV allowed for a significantly higher rate of clear margins: 33 (52.4 %), 104 (68.0 %) and 142 (84.5 %), respectively (p < 0.001). It also allowed for a significantly higher probability of achieving both negative margins and depth of specimen <10 mm: 10 (15.9 %) cases, 47 (30.7 %) cases and 125 (74.4 %) cases, respectively (p < 0.001). In multivariate analysis, when compared with the use of previous colposcopy report or with colposcopy immediately before the LLETZ, DCV allowed for a significantly higher probability of negative margins (AOR: 4.61; 95 % CI: 2.37–8.99 and AOR: 2.55; 95 % CI: 1.47–4.41), combined negative margins and depth <75th percentile (AOR: 3.67; 95 % CI: 1.97–6.86 and AOR: 3.05; 95 % CI: 1.91–4.87) and combined negative margins and volume <75th percentile (AOR: 12.96; 95 % CI: 5.99–28.05 and AOR: 6.16; 95 % CI: 3.75–10.14), respectively. When used with the LLETZ procedure, DCV allows for optimal outcomes in terms of negative resection margins, and minimized depth and volume of the excised specimen; and should therefore be recommended.
Comparison of glyburide and insulin in women with gestational diabetes mellitus and associated perinatal outcome: a randomized clinical trial.

Insulin is currently the drug of choice in treating patients with gestational diabetes mellitus but insulin is expensive, inconvenient to store and use and probably associated with more risks of asymptomatic hypoglycemia in comparison with some oral agents. This randomized clinical trial was conducted to evaluate the efficacy and safety of glyburide in patients with gestational diabetes mellitus in comparison with insulin therapy. Pregnant women aged between 18-45 years with singleton pregnancies and in their 24-36 weeks of gestation were assessed for eligibility. Women with gestational diabetes mellitus were randomly allocated to two insulin and glyburide groups and compared with maternal and neonatal outcome. Ninety-six women with gestational diabetes mellitus enrolled in the study. At screen and treated fasting and post-prandial blood glucose levels were similar in both groups. Time for beginning the treatment to control the glycemic index was 28.30 (±20.60) days in the insulin group and 22.56 (±18.86) in the glyburide group. There was no statistically significant difference in time-to-control the blood glucose level in two studied group. Time, between beginning the treatment of GDM and delivery, was 53.22 (±28.96) days in the insulin group and 56.67 (±30.47) in the glyburide group. There was no statistically significant difference between the times of treatment-to-delivery in two studied groups. There were no statistically significant differences between maternal and neonatal outcomes in two studied groups. Glyburide can effectively and safely control the glycemic index in women with gestational diabetes mellitus in comparison with insulin.
Brain-machine interface in chronic stroke rehabilitation: a controlled study.

Chronic stroke patients with severe hand weakness respond poorly to rehabilitation efforts. Here, we evaluated efficacy of daily brain-machine interface (BMI) training to increase the hypothesized beneficial effects of physiotherapy alone in patients with severe paresis in a double-blind sham-controlled design proof of concept study.



Thirty-two chronic stroke patients with severe hand weakness were randomly assigned to 2 matched groups and participated in 17.8 ± 1.4 days of training rewarding desynchronization of ipsilesional oscillatory sensorimotor rhythms with contingent online movements of hand and arm orthoses (experimental group, n = 16). In the control group (sham group, n = 16), movements of the orthoses occurred randomly. Both groups received identical behavioral physiotherapy immediately following BMI training or the control intervention. Upper limb motor function scores, electromyography from arm and hand muscles, placebo-expectancy effects, and functional magnetic resonance imaging (fMRI) blood oxygenation level-dependent activity were assessed before and after intervention.



A significant group × time interaction in upper limb (combined hand and modified arm) Fugl-Meyer assessment (cFMA) motor scores was found. cFMA scores improved more in the experimental than in the control group, presenting a significant improvement of cFMA scores (3.41 ± 0.563-point difference, p = 0.018) reflecting a clinically meaningful change from no activity to some in paretic muscles. cFMA improvements in the experimental group correlated with changes in fMRI laterality index and with paretic hand electromyography activity. Placebo-expectancy scores were comparable for both groups.



The addition of BMI training to behaviorally oriented physiotherapy can be used to induce functional improvements in motor function in chronic stroke patients without residual finger movements and may open a new door in stroke neurorehabilitation.
Initiating insulin therapy in type 2 Diabetes: a comparison of biphasic and basal insulin analogs.

Safety and efficacy of biphasic insulin aspart 70/30 (BIAsp 70/30, prebreakfast and presupper) were compared with once-daily insulin glargine in type 2 diabetic subjects inadequately controlled on oral antidiabetic drugs (OADs).



This 28-week parallel-group study randomized 233 insulin-naive patients with HbA(1c) values >/=8.0% on >1,000 mg/day metformin alone or in combination with other OADs. Metformin was adjusted up to 2,550 mg/day before insulin therapy was initiated with 5-6 units BIAsp 70/30 twice daily or 10-12 units glargine at bedtime and titrated to target blood glucose (80-110 mg/dl) by algorithm-directed titration.



A total of 209 subjects completed the study. At study end, the mean HbA(1c) value was lower in the BIAsp 70/30 group than in the glargine group (6.91 +/- 1.17 vs. 7.41 +/- 1.24%, P < 0.01). The HbA(1c) reduction was greater in the BIAsp 70/30 group than in the glargine group (-2.79 +/- 0.11 vs. -2.36 +/- 0.11%, respectively; P < 0.01), especially for subjects with baseline HbA(1c) >8.5% (-3.13 +/- 1.63 vs. -2.60 +/- 1.50%, respectively; P < 0.05). More BIAsp 70/30-treated subjects reached target HbA(1c) values than glargine-treated subjects (HbA(1c) </=6.5%: 42 vs. 28%, P < 0.05; HbA(1c) <7.0%: 66 vs. 40%, P < 0.001). Minor hypoglycemia (episodes/year) was greater in the BIAsp 70/30 group than in the glargine group (3.4 +/- 6.6 and 0.7 +/- 2.0, respectively; P < 0.05). Weight gain and daily insulin dose at study end were greater for BIAsp 70/30-treated subjects than for glargine-treated subjects (weight gain: 5.4 +/- 4.8 vs. 3.5 +/- 4.5 kg, P < 0.01; insulin dose: 78.5 +/- 39.5 and 51.3 +/- 26.7 units/day, respectively).



In subjects with type 2 diabetes poorly controlled on OADs, initiating insulin therapy with twice-daily BIAsp 70/30 was more effective in achieving HbA(1c) targets than once-daily glargine, especially in subjects with HbA(1c) >8.5%.