nils-herrmann/clean_scirepeval huggingface dataset:
Patient self-appraisal of change and minimal clinically important difference on the European organization for the research and treatment of cancer quality of life questionnaire core 30 before and during cancer therapy

Clinical interpretation of health related quality of life (HRQOL) scores is challenging. The purpose of this analysis was to interpret score changes and identify minimal clinically important differences (MCID) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) before (T1) and during (T2) cancer treatment. Patients (N = 627) in stem cell transplant (SCT) and medical (MED) or radiation (RAD) oncology at two comprehensive cancer centers, enrolled in the Electronic Self-Report Assessment-Cancer study and completed the QLQ-C30 at T1 and T2. Perceived changes in five QOL domains, physical (PF), emotional (EF), social (SF), cognitive functioning (CF) and global quality of life (QOL), were reported using the Subject Significance Questionnaire (SSQ) at T2. Anchored on SSQ ratings indicating “improvement”, “the same”, or “deterioration”, means and effect sizes were calculated for QLQ-C30 score changes. MCID was calculated as the mean difference in QLQ-C30 score changes reflecting one category change on SSQ rating, using a two-piece linear regression model. A majority of SCT patients (54%) perceived deteriorating global HRQOL versus improvement (17%), while approximately equal proportions of MED/RAD patients perceived improvement (25%) and deterioration (26%). Global QOL decreased 14.2 (SCT) and 2.0 (MED/RAD) units, respectively, among patients reporting “the same” in the SSQ. The MCID ranged 5.7-11.4 (SCT) and 7.2-11.8 (MED/RAD) units among patients reporting deteriorated HRQOL; ranged 2.7-3.4 units among MED/RAD patients reporting improvement. Excepting for the global QOL (MCID =6.9), no meaningful MCID was identified among SCT patients reporting improvement. Cancer treatment has greater impact on HRQOL among SCT patients than MED/RAD patients. The MCID for QLQ-C30 score change differed across domains, and differed for perceived improvement and deterioration, suggesting different standards for self-evaluating changes in HRQOL during cancer treatment. Specifically, clinical attention can be focused on patients who report at least a 6 point decrease, and for patients who report at least a 3 point increase on QLQ-C30 domains.
Clofarabine with high dose cytarabine and granulocyte colony-stimulating factor (G-CSF) priming for relapsed and refractory acute myeloid leukaemia.

This phase I/II study was conducted to determine the maximum tolerated dose, toxicity, and efficacy of clofarabine in combination with high dose cytarabine and granulocyte colony-stimulating factor (G-CSF) priming (GCLAC), in the treatment of patients with relapsed or refractory acute myeloid leukaemia (AML). Dose escalation of clofarabine occurred without dose-limiting toxicity, so most patients were treated at the maximum dose, 25 mg/m(2) per day with cytarabine 2 g/m(2) per day, each for 5 d, and G-CSF 5 μg/kg, beginning the day before chemotherapy and continuing daily until neutrophil recovery. The complete remission (CR) rate among the 46 evaluable patients was 46% (95% confidence interval [CI] 31-61%) and the CR + CR but with a platelet count <100 × 10(9)/l rate was 61% (95% CI 45-75%). Multivariate analysis showed that responses to GCLAC were independent of age, cytogenetic risk category, and number of prior salvage regimens. GCLAC is highly active in relapsed and refractory AML and warrants prospective comparison to other regimens, as well as study in untreated patients.
Tiotropium improves walking endurance in COPD.

The primary objective of this study was to evaluate the effects of a 3-week treatment with tiotropium on walking capacity in chronic obstructive pulmonary disease (COPD). After familiarisation with study procedures, 36 patients were randomised to receive tiotropium 18 μg once daily or a matching placebo in a double-blind, parallel-group study. Pre- (trough) and 2-h post-dose pulmonary function was measured. An endurance shuttle walk was then completed. The same procedures were repeated after 3 weeks of treatment. Ventilatory parameters were monitored during exercise. At 3 weeks, tiotropium significantly improved walking endurance time in comparison with placebo, with a mean±sd between-group difference of 128±141 s (p=0.017). At 3 weeks, trough values for forced expiratory volume in 1 s (FEV(1)) and forced vital capacity (FVC) were significantly improved with tiotropium in comparison with placebo. The post-dose response to tiotropium was statistically superior to placebo after the first dose and after 3 weeks of treatment for FEV(1), FVC and inspiratory capacity. Ventilation and tidal volume at the end of walking were significantly improved with tiotropium. 3 weeks of tiotropium resulted in a greater walking endurance in patients with COPD. Improvements in FEV(1), maximal ventilation and tidal volume may contribute to this enhanced exercise capacity.
Gastric PgCO2 and Pg-aCO2 gap are related to d-lactate and not to l-lactate levels in patients with septic shock

Intestinal ischemia causes an increase in lactate production and gastric intramucosal carbon dioxide partial pressure (PgCO2). However, no linear relationship between systemic l-lactate levels and gastric tonometry during intestinal ischemia has been found, probably since l-lactate is rapidly cleared from the circulation by the liver. In contrast, the rate of d-lactate clearance from the circulation by the liver is considerably lower than that of l-lactate, and d-lactate may therefore be more closely related to measurements of gastric tonometry than l-lactate values. Prospective, observational study in a university-affiliated mixed intensive care unit. Twenty critically ill patients with septic shock. During the first 24 h of admission to the intensive care unit at least two blood samples were taken for d- and l-lactate measurements and arterial blood gases, Simultaneously, gastric PgCO2 was measured using capnographic tonometry. The intramucosal-arterial PCO2 gap was calculated using gastric intramucosal PgCO2 and arterial PCO2 from arterial blood. d-Lactate was significantly correlated to PgCO2 values and to the mucosal-arterial PCO2 gap. There was no relationship between l-lactate and PgCO2 or the mucosal-arterial PCO2 gap. d-lactate and l-lactate values were significantly correlated. During sepsis intestinal production of d-lactate is related to gastric intramucosal PCO2. No such relationship was found between l-lactate values and PgCO2
Platelet-rich plasma prevents blood loss and pain and enhances early functional outcome after total knee arthroplasty: a prospective randomised controlled study

The purpose of this study was to determine whether platelet-rich plasma (PRP) might prevent blood loss and postoperative pain and expedite wound healing following total knee arthroplasty (TKA). Forty consecutive patients with knee arthritis who were matched for age, sex and body mass index (BMI) were randomly allocated to either receive or not receive PRP application over the wound, including capsule, medial and lateral recesses, during TKA. Postoperative haemoglobin, blood loss, blood transfusion, visual analogue scale (VAS) score, wound score, Knee Society Score (KSS) and Western Ontario and McMaster Osteoarthritis Index (WOMAC) score were recorded and evaluated. The platelet-rich plasma and control groups comprised 17 and 23 patients, respectively. The PRP group recorded significantly less reduction in haemoglobin and need for blood transfusion (p = 0.00 and p = 0.001, respectively), experienced less pain (p = 0.00) and required fewer narcotics than the control (p = 0.00). There was significant difference in range of motion (ROM) at three months (p = 0.01), no significant difference in wound scores (p = 0.311) and significant difference in KSS and WOMAC scores at 12 weeks (p = 0.00, 0.00). However no significant difference was found at six months. PRP has significant effect in preventing blood loss, postoperative pain and need for narcotics after TKA and has a positive effect on short-term clinical outcome.
Geographic and Sociodemographic Disparities in Drive Times to Joint Commission–Certified Primary Stroke Centers in North Carolina, South Carolina, and Georgia

Timely access to facilities that provide acute stroke care is necessary to reduce disabilities and death from stroke. We examined geographic and sociodemographic disparities in drive times to Joint Commission-certified primary stroke centers (JCPSCs) and other hospitals with stroke care quality improvement initiatives in North Carolina, South Carolina, and Georgia.



We defined boundaries for 30- and 60-minute drive-time areas to JCPSCs and other hospitals  by  using geographic information systems (GIS) mapping technology and calculated the proportions of the population living in these drive-time areas by sociodemographic characteristics. Age-adjusted county-level stroke death rates were overlaid onto the drive-time areas.



Approximately 55% of the population lived within a 30-minute drive time to a JCPSC; 77% lived within a 60-minute drive time. Disparities in percentage of the population within 30-minute drive times were found by race/ethnicity, education, income, and urban/rural status; the disparity was largest between urban areas (70% lived within 30-minute drive time) and rural areas (26%). The rural coastal plains had the largest concentration of counties with high stroke death rates and the fewest JCPSCs.



Many areas in this tri-state region lack timely access to JCPSCs. Alternative strategies are needed to expand provision of quality acute stroke care in this region. GIS modeling is valuable for examining and strategically planning the distribution of hospitals providing acute stroke care.
p66 Shc and tyrosine-phosphorylated Shc in primary breast tumors identify patients likely to relapse despite tamoxifen therapy

Shc adapter proteins are secondary messenger proteins involved in various cellular pathways, including those mediating receptor tyrosine kinase signaling and apoptosis in response to stress. We have previously reported that high levels of tyrosine-phosphorylated Shc (PY-Shc) and low levels of its inhibitory p66 Shc isoform are strongly prognostic for identifying both early node-negative and more advanced, node-positive, primary breast cancers with high risk for recurrence. Because aberrant activation of tyrosine kinases upstream of Shc signaling proteins has been implicated in resistance to tamoxifen – the most widely prescribed drug for treatment of estrogen receptor-positive breast cancer – we hypothesized that Shc isoforms may identify patients at increased risk of relapsing despite tamoxifen treatment. Immunohistochemical analyses of PY-Shc and p66 Shc were performed on archival primary breast cancer tumors from a population-based cohort (60 patients, 9 relapses) and, for validation, an independent external cohort (31 patients, 13 relapses) in which all patients received tamoxifen as a sole systemic adjuvant prior to relapse. By univariate and multivariate analyses, the Shc proteins were very strong and independent predictors of treatment failure in both the population-based cohort (interquartile hazard ratio = 8.3, 95% confidence interval [CI] 1.8 to 38, P = 0.007) and the validating cohort (interquartile relative risk = 12.1, 95% CI 1.7 to 86, P = 0.013). These results suggest that the levels of PY-Shc and p66 Shc proteins in primary tumors identify patients at high risk for relapsing despite treatment with tamoxifen and therefore with further validation may be useful in guiding clinicians to select alternative adjuvant treatment strategies.
Impact of a parent-based interdisciplinary intervention for mothers on adjustment in children newly diagnosed with cancer.

To determine if maternal distress predicts child adjustment outcomes or if child adjustment outcomes predict maternal distress among children newly diagnosed with cancer, and if a parent-focused intervention has downstream effects on child adjustment.



Mothers (n = 52) were randomly assigned to a clinic-based, interdisciplinary intervention for parents of children newly diagnosed with cancer. Measures of maternal distress and child adjustment were collected at baseline, posttreatment, and follow-up.



A lagged relationship was identified between maternal distress and child internalizing symptoms, but not externalizing symptoms. The parent intervention reduced child internalizing and externalizing symptoms at follow-up. Only the child internalizing symptoms effect was mediated by reduced maternal distress. The child externalizing symptoms effect was mediated by unobserved parent factors.



This study provides support for illness adjustment and coping models that emphasize the role of parent factors in driving child adjustment outcomes and is encouraging for future parent-focused intervention research.
A phase III study of the safety and efficacy of viramidine versus ribavirin in treatment-naïve patients with chronic hepatitis C: ViSER1 results.

Pegylated interferon (peg-IFN) and ribavirin (RBV) are effective in eradicating the hepatitis C virus in more than half of patients. However, anemia arising from RBV-induced hemolysis can prompt dose reductions and lower sustained virologic response (SVR) rates. In early clinical trials, Viramidine (VRD, renamed taribavirin), an RBV prodrug, was associated with less anemia and VRD given at 600 mg twice daily (BID) appeared to provide the best safety with comparable efficacy to RBV. The phase III Viramidine's Safety and Efficacy versus Ribavirin 1 (ViSER1) study randomized 972 treatment-naïve patients with chronic hepatitis C to fixed-dose VRD (600 mg BID) or weight-based RBV (1000 or 1200 mg/day), each given with peg-IFN alfa-2b at 1.5 microg/kg/week. The primary efficacy endpoint was SVR rate, and the primary safety endpoint was hemoglobin (Hb) event rate (percent of patients with Hb < 10 g/dL or at least a 2.5-g/dL decrease from baseline). SVR rates were 37.7% with VRD (244/647) and 52.3% with RBV (170/325). Thus, the ViSER1 study failed to demonstrate the primary noninferiority efficacy endpoint. Significantly fewer patients had Hb events with VRD (353/647; 54.6%) compared to those with RBV (272/325; 83.7%) (P < 0.001), and significantly fewer developed anemia (Hb < 10 g/dL) with VRD (34/647; 5.3%) compared to those with RBV (76/325; 23.5%) (P < 0.001).



Fixed doses of VRD failed to demonstrate noninferiority to RBV in producing SVR rates. The incidence of anemia was approximately four-fold significantly lower with VRD than with RBV. These results suggest fixed-dose VRD given 600 mg BID is insufficient to treat patients with chronic hepatitis C; a weight-based dosing trial of viramidine is currently under way.
Decellularized aortic homografts for aortic valve and aorta ascendens replacement†

The choice of valve prosthesis for aortic valve replacement (AVR) in young patients is challenging. Decellularized pulmonary homografts (DPHs) have shown excellent results in pulmonary position. Here, we report our early clinical results using decellularized aortic valve homografts (DAHs) for AVR in children and mainly young adults.



This prospective observational study included all 69 patients (44 males) operated from February 2008 to September 2015, with a mean age of 19.7 ± 14.6 years (range 0.2-65.3 years). In 18 patients, a long DAH was used for simultaneous replacement of a dilated ascending aorta as an extended aortic root replacement (EARR). Four patients received simultaneous pulmonary valve replacement with DPH.



Thirty-nine patients (57%) had a total of 62 previous operations. The mean aortic cross-clamp time in isolated cases was 129 ± 41 min. There was 1 conduit-unrelated death. The mean DAH diameter was 22.4 ± 3.7 mm (range, 10-29 mm), the average peak gradient was 14 ± 15 mmHg and the mean aortic regurgitation grade (0.5 = trace, 1 = mild) was 0.6 ± 0.5. The mean effective orifice area (EOA) of 25 mm diameter DAH was 3.07 ± 0.7 cm(2). DAH annulus z-values were 1.1 ± 1.1 at implantation and 0.7 ± 1.3 at the last follow-up. The last mean left ventricle ejection fraction and left ventricle end diastolic volume index was 63 ± 7% and 78 ± 16 ml/m(2) body surface area, respectively. To date, no dilatation has been observed at any level of the graft during follow-up; however, the observational time is short (140.4 years in total, mean 2.0 ± 1.8 years, maximum 7.6 years). One small DAH (10 mm at implantation) had to be explanted due to subvalvular stenosis and developing regurgitation after 4.5 years and was replaced with a 17 mm DAH without complication. No calcification of the explanted graft was noticed intraoperatively and after histological analysis, which revealed extensive recellularization without inflammation.



DAHs withstand systemic circulation, provide outstanding EOA and appear as an alternative to conventional grafts for AVR in young patients. EARR using DAH is a further option in aortic valve disease associated with aorta ascendens dilatation as it avoids the use of any prosthetic material.
CHOP is superior to CNOP in elderly patients with aggressive lymphoma while outcome is unaffected by filgrastim treatment: results of a Nordic Lymphoma Group randomized trial.

This study was designed to test the hypothesis that administration of granulocyte colony-stimulating factor (G-CSF; filgrastim) during induction chemotherapy with CHOP (cyclophosphamide, vincristine, doxorubicin, prednisone) or CNOP (doxorubicin replaced with mitoxantrone) in elderly patients with aggressive non-Hodgkin lymphoma (NHL) improves time to treatment failure (TTF), complete remission (CR) rate, and overall survival (OS). Furthermore, the efficacy of CHOP versus CNOP chemotherapy was compared. A total of 455 previously untreated patients older than 60 years with stages II to IV aggressive NHL were included in the analysis. Patients (median age, 71 years; range, 60-86 years) were randomized to receive CHOP (doxorubicin 50 mg/m(2)) or CNOP (mitoxantrone 10 mg/m(2)) with or without G-CSF (5 microg/kg from day 2 until day 10-14 of each cycle every 3 weeks; 8 cycles). Forty-seven patients previously hospitalized for class I to II congestive heart failure were randomized to receive CNOP with or without G-CSF (not included in the CHOP versus CNOP analysis). The CR rates in the CHOP/CNOP plus G-CSF and CHOP/CNOP groups were the same, 52%, and in the CHOP with or without G-CSF and CNOP with or without G-CSF groups, 60% and 43% (P <.001), respectively. No benefit of G-CSF in terms of TTF and OS could be shown (P =.96 and P =.22, respectively), whereas CHOP was superior to CNOP (TTF/OS P <.001). The incidences of severe granulocytopenia (World Health Organization grade IV) and granulocytopenic infections were higher in patients not receiving G-CSF. The cumulative proportion of patients receiving 90% or more of allocated chemotherapy was higher (P <.05) in patients receiving G-CSF. Concomitant G-CSF treatment did not improve CR rate, TTF, or OS. Patients receiving CHOP fared better than those given CNOP chemotherapy. The addition of G-CSF reduces the incidence of severe granulocytopenia and infections in elderly patients with aggressive NHL receiving CHOP or CNOP chemotherapy.
Simulated Physician Learning Program Improves Glucose Control in Adults With Diabetes

Inexpensive and standardized methods to deliver medical education to primary care physicians (PCPs) are desirable. Our objective was to assess the impact of an individualized simulated learning intervention on diabetes care provided by PCPs.



Eleven clinics with 41 consenting PCPs in a Minnesota medical group were randomized to receive or not receive the learning intervention. Each intervention PCP was assigned 12 simulated type 2 diabetes cases that took about 15 min each to complete. Cases were designed to remedy specific physician deficits found in their electronic medical record observed practice patterns. General linear mixed models that accommodated the cluster randomized study design were used to assess patient-level change from preintervention to 12-month postintervention of A1C, blood pressure, and LDL cholesterol. The relationship between the study arm and the total of intervention and patient health care costs was also analyzed.



Intervention clinic patients with baseline A1C >or=7% significantly improved glycemic control at the last postintervention A1C measurement, intervention effect of -0.19% mean A1C (P = 0.034) and +6.7% in A1C <7% goal achievement (P = 0.0099). Costs trended lower, with the cost per patient -$71 (SE = 142, P = 0.63) relative to nonintervention clinic patients. The intervention did not significantly improve blood pressure or LDL control. Models adjusting for age, sex, and comorbidity showed similar results. PCPs reported high satisfaction.



A brief individualized case-based simulated learning intervention for PCPs led to modest but significant glucose control improvement in adults with type 2 diabetes without increasing costs.
A randomized, controlled trial of emotional disclosure in rheumatoid arthritis: Can clinician assistance enhance the effects?

Emotional disclosure by writing or talking about stressful life experiences improves health status in non-clinical populations, but its success in clinical populations, particularly rheumatoid arthritis (RA), has been mixed. In this randomized, controlled trial, we attempted to increase the efficacy of emotional disclosure by having a trained clinician help patients emotionally disclose and process stressful experiences. We randomized 98 adults with RA to one of four conditions: (a) private verbal emotional disclosure; (b) clinician-assisted verbal emotional disclosure; (c) arthritis information control (all of which engaged in four, 30-min laboratory sessions); or (d) no-treatment, standard care only control group. Outcome measures (pain, disability, affect, stress) were assessed at baseline, 2 months following treatment (2-month follow-up), and at 5-month, and 15-month follow-ups. A manipulation check demonstrated that, as expected, both types of emotional disclosure led to immediate (post-session) increases in negative affect compared with arthritis information. Outcome analyses at all three follow-ups revealed no clear pattern of effects for either clinician-assisted or private emotional disclosure compared with the two control groups. There were some benefits in terms of a reduction in pain behavior with private disclosure vs. clinician-assisted disclosure at the 2-month follow-up, but no other significant between group differences. We conclude that verbal emotional disclosure about stressful experiences, whether conducted privately or assisted by a clinician, has little or no benefit for people with RA.