bluuebunny/crossref_metadata_2025_split huggingface dataset:
Adherence to oral chemotherapy: Challenges and opportunities
Authors: Krikorian Susan , Pories Susan , Tataronis Gary , Caughey Thomas , Chervinsky Kirsten , Lotz Margaret , Shen Abra H , Weissmann Lisa 
Published: September 2018

Purpose There is very little data on the effect of combining methods to better predict and improve oral antineoplastic adherence in cancer patients. The goal of this study was to evaluate the effectiveness of an intensive pharmacist intervention at the beginning of oral antineoplastic therapy versus nurse-led control group on adherence. Methods This was a prospective, randomized, open-label controlled trial performed in a single center hematology/oncology outpatient service to compare the effectiveness of repetitive pharmacist educational intervention on adherence rates measured at four and eight weeks after prescribing oral antineoplastic medication compared to a nurse-led control group. Both groups included investigator pill counts and self-report adherence questionnaires. Results Two-hundred patients were enrolled between 2009 and 2015. Fourteen of the 101 (14%) patients in the pharmacist group and 7 (7%) of the 99 patients in the nurse-led control group dropped out ( p = 0.166). The majority of patients who remained in the study were 90–100% adherent to oral antineoplastic therapy in both groups. The pharmacist group slightly underperformed at Pill Count 2, possibly due to barriers for non-adherence. Statistically significant correlations associated with non-adherence were forgetfulness ( p = 0.009), wanting to avoid side effects ( p = 0.02), feeling depressed or overwhelmed ( p = 0.032), or falling asleep before taking medication ( p = 0.048) in both groups. Conclusion The combination of pill count and patient self-report adherence is a way of improving oral antineoplastic adherence. However, significant barriers to adherence were identified such as forgetfulness, wanting to avoid side effects, feeling depressed or overwhelmed, and falling asleep before taking medications.
Drug interactions between tyrosine kinase inhibitors (gefitinib and erlotinib) and warfarin: Assessment of international normalized ratio elevation characteristics and in vitro CYP2C9 activity
Authors: Hiraide Makoto , Minowa Yuichi , Nakano Yasuhiro , Suzuki Kenichi , Shiga Taro , Nishio Makoto , Miyoshi Junya , Takahashi Harumi , Hama Toshihiro 
Published: September 2018

Background Elevation of the international normalized ratio and bleeding complications has been reported in patients taking warfarin concomitantly with tyrosine kinase inhibitors such as gefitinib and erlotinib. Objective To assess the frequency, degree, and onset of international normalized ratio elevation in patients receiving warfarin with gefitinib or erlotinib, and changes in vitro cytochrome P450 2C9 activity. Methods This retrospective, single-center, observational study compared international normalized ratio values during the treatment with warfarin in the absence and presence of the tyrosine kinase inhibitors, gefitinib, and erlotinib. In addition, the inhibitory effect of tyrosine kinase inhibitors on cytochrome P450 2C9 activity was screened in an in vitro study. Results Compared with international normalized ratio at the baseline significant ( P < 0.05) international normalized ratio elevations were observed in the majority of the patients (5/6 patients with gefitinib, 83.3%; 6/7 patients with erlotinib, 85.7%) during concurrent therapy. The international normalized ratio was increased 1.8- and 1.6-fold relative to the baseline value, on median, in the presence of gefitinib and erlotinib, respectively, and the onset of international normalized ratio elevation was observed at a median of seven days and nine days, respectively. In vitro (S)-warfarin 7-hydroxylation activity was inhibited by 36% in the presence of 1 µM gefitinib and 27% by 10 µM erlotinib, which are comparable to the steady-state plasma levels of these tyrosine kinase inhibitors after standard dosing. Conclusion In most patients, international normalized ratio elevation was observed within two weeks of the start of concomitant therapy with warfarin and gefitinib or erlotinib. To avoid excessive anticoagulant response by warfarin, international normalized ratio should be carefully monitored weekly and dosage adjustment of warfarin might be recommended during the first month after the start of concurrent tyrosine kinase inhibitor therapy.
Biomechanical efficacy of corneal cross-linking using hypoosmolar riboflavin solution
Authors: Wollensak Gregor , Spörl Eberhard 
Published: September 2018

Purpose: The use of hypoosmolar riboflavin solution has been suggested for cross-linking thin corneas. The aim of this study was to compare the biomechanical efficacy of corneal cross-linking using hypoosmolar dextran-free riboflavin solution (HCXL) versus isoosmolar standard corneal cross-linking treatment (CXL). Methods: A total of 24 postmortem porcine eyes with debrided corneas were subdivided into three treatment groups: Controls, the isoosmolar group with isoosmolar 0.1% riboflavin-20% dextran solution and the hypoosmolar group with dextran-free, 0.1% riboflavin solution. The samples were irradiated with UVA light of 365 nm wavelength and an irradiance of 3 mW/cm² for 30 min (dose 5.4 J/cm²). For the biomechanical measurements, 400-µm-deep anterior corneal flaps were created using a lamellar rotating microkeratome. Uniaxial stress–strain measurements were performed. Results: In the isoosmolar treatment group, stress and Young’s modulus at 8% strain were significantly increased by 67.97%, respectively, 62.62% versus the controls. In the hypoosmolar treatment group, stress and Young’s modulus at 8% strain were significantly increased by 81.21%, respectively, 51.40% versus the controls. There was no significant difference between the iso- and hypoosmolar groups in biomechanical efficacy. On histology, there was no edema in the anterior 200 µm of the corneas after stromal swelling by the hypoosmolar riboflavin solution. Conclusion: Corneal cross-linking using isoosmolar or hypoosmolar riboflavin solution induces a comparable biomechanical effect. This is explained by the localization of the maximum cross-linking effect in the anterior 200 µm of the cornea which are not affected by the swelling effect of hypoosmolar riboflavin solution.
Into the unknown: Treatment as a social arena for drug users’ transition into a non-using life
Authors: Robertson Inger Eide , Nesvåg Sverre Martin 
Published: September 2018

Background and aims: For people trying to stop using alcohol or other drugs (AOD), the process is often characterised by periods of abstinence followed by relapse into their previous drug-related way of life and subsequent re-entry into the treatment system. There is a call for greater attention to the how of these transitions, with a special focus on the phase of leaving treatment. The aim of this article was to get a better understanding of the transformation of practice when moving from a drug-using to a non-using lifestyle by exploring the experience of (1) the involvement in treatment settings, (2) the process of leaving treatment, and finally, (3) the early phase of changing everyday practice into a drug-free way of living. Method: The article takes on a social practice approach, in particular Bourdieu’s concepts of habitus, “doxa” and field to analyse 17 in-depth interviews with Norwegian men and women seeking treatment for problems resulting from the use of drugs and/or alcohol. Results: The study shows that the support of professionals operates as transitional relations that can bridge the transformation from a drug-using to a drug-free life, by providing a social web of relations, positions, settings and activities. However, leaving treatment and establishing AOD-free practice involves moving into something unknown in the sense that there is no embodied, taken-for-granted knowledge about how to relate to a world where drug use is not the focal point of existence. Conclusions: The process of change, then, involves being exposed to an existential feeling of maladjustment. To get beyond the feeling of maladjustment, and get into the doxic mode takes time, and involves reconfiguration of habitus through reorientation of social settings, relations and networks. The treatment system could potentially develop a continuum of support during these transformations.
An evaluation of reporting of consent declines in three high impact factor journals
Authors: Figer BH , Thaker SJ , Boob M , Gogtay NJ , Thatte UM 
Published: September 2018

Background Informed consent confers upon participants the right to decline or accept participation in a study in equal measure. Consent declines can be used as a potential metric to assess the adequacy of the informed consent process. Limited literature is available on the reporting of consent declines in Clinical Research. We evaluated randomized controlled trials published in three high-impact factor journals for consent declines (four-year period) to assess the extent of exertion of autonomy by research participants. Methods CONSORT flow charts in RCTs published in New England Journal of Medicine (NEJM), The Lancet and Journal of the American Medical Association (JAMA) between 2012 and 2015 were evaluated. The total and per journal proportion of RCTs reporting consent declines was calculated. Percentage of consent declines was also compared based on number of centers (single centric vs. multicentric) and type of setting (developed vs. developing). Between-groups analysis was done using Chi Square, Chi Square for trend and a Crude odds ratio [95% C.I] (cOR) were calculated. Results Only 3.7% (1103/29,825) of the published articles were RCTs. Of the 1103 RCTs, only 532 (48.2%) reported consent declines. JAMA had the highest RCTs reporting consent declines (171/267.64%), the Lancet [129,150/781,924, 16.5%] had the most participants declining consent. Difference was significant using Chi square for linear trend [ p < 0.00001]. Consent decline rate was higher in developed countries relative to developing countries [cOR(95% C.I): 2.27(2.23,2.32), p < 0.000001] and in single centric versus multicentric studies [cOR (95% C.I): 3.63(3.56,3.71), p < 0.0000001]. Conclusion Both authors and journal editors need to ensure better reporting of consent declines.
t-BHQ Protects Against Oxidative Damage and Maintains the Antioxidant Response in Malnourished Rats
Authors: Gavia-García Graciela , Rosas-Trejo María de los Ángeles , García-Mendoza Eduardo , Toledo-Pérez Rafael , Königsberg Mina , Nájera-Medina Oralia , Luna-López Armando , González-Torres María Cristina 
Published: September 2018

Objective: Tert-butylhydroquinone (t-BHQ) protective effect against oxidative damage in thymus from malnourished pops-rats was evaluated. Methods: Malnutrition in pops-rats was induced during the lactation period and first-, second-, and third-degree malnourished rats were studied (MN1, MN2, and MN3). To determine t-BHQ protective effect, lipid peroxidation (LPx) was assessed, as well as the carbonyl content. The reduced glutathione and glutathione disulfide content were determined and antioxidant enzyme activities were measured. Results: Oxidative protein damage, LPx, and Nuclear Factor-κB (NF-κB) content, increased in the MN2 and MN3 compared to well-nourished rats, associated with lower protein content and antioxidant activity of superoxide dismutase (SOD), glutathione peroxidase (GPx), and catalase. Tert-butylhydroquinone treatment induced a protective effect against lipids and proteins oxidative damage, as well as decrease in NF-κB in MN rats and restored the antioxidant mechanisms, mostly GPx and SOD. No differences were found between male and female animals. Conclusions: Results show that higher body weight deficit leads to increased oxidative damage and probably inflammation, attributable to alterations in antioxidant mechanisms. These effects were reversed by the t-BHQ-treatment, which restores the antioxidant response. Our findings suggest that t-BHQ could be an interesting pharmacological intervention, but it needs to be studied further.
Is Thermal Imaging a Useful Predictor of the Healing Status of Diabetes-Related Foot Ulcers? A Pilot Study
Authors: Aliahmad Behzad , Tint Aye Nyein , Poosapadi Arjunan Sridhar , Rani Priya , Kumar Dinesh Kant , Miller Julie , Zajac Jeffrey D. , Wang Gayathiri , Ekinci Elif Ilhan 
Published: September 2018

Introduction: In clinical practice, both area and temperature of the ulcer have been shown to be effective in tracking the healing status of diabetes-related foot ulcer (DRFU). However, traditionally, the area of the DRFU is measured regardless of the temperature distribution. The current prospective, observational study used thermal imaging, as a more accurate tool, to measure both the area and the temperature of DRFU. We aimed to predict healing of DRFU using thermal imaging within the first 4 weeks of ulceration. Method: A pilot study was conducted where thermal and color images of 26 neuropathic DRFUs (11 healing vs 15 nonhealing) from individuals with type 1 or 2 diabetes were taken at the initial clinic visit (baseline), at week 2, and at week 4. The thermal images were segmented into isothermal patches to identify the wound boundary and area corresponding to temperature distribution. Five parameters were obtained: temperature of the wound bed, area of the isothermal patch of the wound bed, area of isothermal patch of periwound, number of isolated isothermal patches of the wound region, and physical wound bed area from color image. The ulcers were also measured by experienced podiatrists over 4 consecutive weeks and used as the healing reference. Results: For healing cases, the ratio of the area of the wound bed to its baseline measured using thermal images was found to be significantly lower at 2 weeks compared to nonhealing cases and this corresponded with a 50% reduction in area of DRFU at 4 weeks (group rank-based nonparametric analysis of variance P = .036). In comparison, neither the planimetric area measured using color images nor the temperature of the wound bed was associated with the healing. Conclusion: This study of 26 patients demonstrates that change in the isothermal area of DRFU can predict the healing status at week 4. Thermal imaging of DRFUs has the advantage of incorporating both area and temperature allowing for early prediction of the healing of these ulcers. Further studies with greater sample sizes are required to test the significance of these results.
Considering Blood Dilution improves the Precision of Continuous Whole Blood Glucose Measurements
Authors: Benesch Carsten , Kuhlenkötter Mareike , Heise Tim 
Published: September 2018

Background:One major advantage of automated over manual clamps are continuous measurements of blood glucose concentrations (BG) allowing frequent adaptations in glucose infusion rates (GIR). However, BG measurements might be affected by changes in blood dilution. ClampArt®, a modern automated clamp device, corrects BG measurements for blood dilution, but the impact of this correction is unclear.Methods:The authors performed a retrospective analysis of BG during glucose clamps comparing values with a fixed dilution factor with those corrected for the actual blood dilution.Results:Clamp quality substantially improved with the consideration of blood dilution: Mean accuracy fell from 8.1% ± 2.9% to 4.1% ± 0.8%, precision improved from 9.6 ± 3.6 mg/dl to 3.7 ± 1.3 mg/dl and control deviation from −2.6 ± 4.2 mg/dl to 0.2 ± 0.2 mg/dl.Conclusions:Correcting continuous BG measurements for blood dilution significantly increases BG measurement and clamp quality.
Detection of serrated lesions in proximal colon by simulated sigmoidoscopy vs faecal immunochemical testing in a multicentre, pragmatic, randomised controlled trial
Authors: Carot Laura , Castells Antoni , Hernández Cristina , Alvarez-Urturi Cristina , Balaguer Francesc , Lanas Angel , Cubiella Joaquín , Tasende Jose D , Jover Rodrigo , Hernandez Vicent , Carballo Fernando , Bujanda Luis , Quintero Enrique , Andreu Montserrat , Bessa Xavier ,   ColonPrev study
Published: September 2018

BackgroundThe diagnostic yield of the faecal immunochemical test and sigmoidoscopy in detecting proximal serrated polyps in a colorectal cancer screening programme has not been fully assessed.AimWe determined the detection rate of proximal serrated polyps by simulated sigmoidoscopy and faecal immunochemical test compared with total colonoscopy in a population‐based, multicentre, nationwide, randomised controlled trial (ColonPrev study).MethodsSigmoidoscopy yield was simulated based on the UK‐Flexible Sigmoidoscopy Trial for total colonoscopy referral. Definitions were: proximal serrated polyp (proximal serrated polyp): sessile serrated polyp or hyperplastic polyp of any size and proximal at‐risk serrated polyp (at‐risk proximal serrated polyp): sessile serrated polyp of any size or hyperplastic polyp ≥ 10 mm, both located proximally to the splenic flexure.ResultsA total of 10,611 individuals underwent faecal immunochemical test and 5059 underwent total colonoscopy and were evaluated by simulated sigmoidoscopy. Sigmoidoscopy and faecal immunochemical test were less accurate in detecting proximal serrated polyps (odds ratio: 0.13; 95% confidence interval: 0.10–0.18 and 0.13; 0.09–0.18, p < 0.0001, respectively). Both tests were inferior to colonoscopy in detecting at‐risk proximal serrated polyps, and sigmoidoscopy was inferior to faecal immunochemical test in detecting these lesions (odds ratio: 0.17; 95% confidence interval: 0.10–0.30 and 0.25; 0.17–0.37, p < 0.0001, respectively).ConclusionSigmoidoscopy and faecal immunochemical test are less accurate in detecting proximal serrated polyps than colonoscopy, particularly in women.
Molecular classification of primary mediastinal large B-cell lymphoma using routinely available tissue specimens
Authors: Mottok Anja , Wright George , Rosenwald Andreas , Ott German , Ramsower Colleen , Campo Elias , Braziel Rita M. , Delabie Jan , Weisenburger Dennis D. , Song Joo Y. , Chan Wing C. , Cook James R. , Fu Kai , Greiner Tim , Smeland Erlend , Holte Harald , Savage Kerry J. , Glinsmann-Gibson Betty J. , Gascoyne Randy D. , Staudt Louis M. , Jaffe Elaine S. , Connors Joseph M. , Scott David W. , Steidl Christian , Rimsza Lisa M. 
Published: September 2018

Abstract
Primary mediastinal large B-cell lymphoma (PMBCL) is recognized as a distinct entity in the World Health Organization classification. Currently, the diagnosis relies on consensus of histopathology, clinical variables, and presentation, giving rise to diagnostic inaccuracy in routine practice. Previous studies have demonstrated that PMBCL can be distinguished from subtypes of diffuse large B-cell lymphoma (DLBCL) based on gene expression signatures. However, requirement of fresh-frozen biopsy material has precluded the transfer of gene expression–based assays to the clinic. Here, we developed a robust and accurate molecular classification assay (Lymph3Cx) for the distinction of PMBCL from DLBCL subtypes based on gene expression measurements in formalin-fixed, paraffin-embedded tissue. A probabilistic model accounting for classification error, comprising 58 gene features, was trained on 68 cases of PMBCL and DLBCL. Performance of the model was subsequently evaluated in an independent validation cohort of 158 cases and showed high agreement of the Lymph3Cx molecular classification with the clinicopathological diagnosis of an expert panel (frank misclassification rate, 3.8%). Furthermore, we demonstrate reproducibility of the assay with 100% concordance of subtype assignments at 2 independent laboratories. Future studies will determine Lymph3Cx’s utility for routine diagnostic purposes and therapeutic decision making.
Comparing self-assessment of laparoscopic technical skills with expert opinion for gynecological surgeons in an operative setting
Authors: Kilani Rami 
Published: September 2018

Abstract
Background
Competence in laparoscopic skills is important for all gynaecological surgeons. Most residency programmes teach technical skills in the operating room and through lectures, where the evaluation of surgical skills is usually done through subjective evaluation. After graduating residency, most surgeons depend on themselves to decide if they are competent in performing a certain procedure. The objective of this study is to evaluate the accuracy of surgeon self-assessment compared with expert assessment of competence in laparoscopic surgical skills. A double-blind prospective cohort study was undertaken at Prince Hamza Hospital between January 2016 and April 2016 in Amman, Jordan. Eight practicing gynecologists and obstetricians performed and recorded 88 laparoscopic procedures including ovarian cystectomy, salpingectomy for ectopic pregnancy, salpingoophorectomy, resection of endometriosis, adhesiolysis and ovarian drilling. Participating gynecologists recorded the procedures and were asked to complete a Global Rating Index of Technical Skills (GRITS) evaluation after the surgery testing across multiple areas with a lowest score of 8 and a highest score of 40. Two well-versed laparoscopic experts in objective structured assessment of technical skills (OSATS) also independently scored all procedures using the same parameters. The correlation coefficient and internal consistency were calculated.

Results
The GRITS score was calculated for each participant with a mean assessment score of 3.47 for each parameter. Participants self-assessment scores were significantly higher than expert assessment scores (p<0.05). The correlation coefficient was calculated and it can be seen that there was high inter-expert correlation in assessment across all participants evaluations (ICC > 0.90).

Conclusion
Self-assessment of surgical laparoscopic skills is higher than expert evaluation of these technical skills. Quality assurance measures need to be revisited and restructured through more frequent assessments using peer and expert assessment alongside self-assessment. Gynecologists also need to undergo proper assessment prior to starting independently performing procedures that require new skills.