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1
Leddin, Desmond. "Alpha Errors, Beta Errors and Negative Trials." Canadian Journal of Gastroenterology 2, no. 4 (1988): 147–50. http://dx.doi.org/10.1155/1988/523841.
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Reports of negative trials arc increasing in number as standard therapy for many gastrointestinal diseases is refined. The validity of a negative report depends on the number of patients in the trial, the alpha and bern error and the difference in efficacy which the trial is able to detect. The relationship between these parameters is discussed and a formula given for the calculation of trial size. All reports of negative trials should include not only the number of patients involved and the level of significance of the results but also the beta error and the detectable difference in efficacy of the treatments.
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Hari, Roman, Kaspar Kälin, Michael Harris, Robin Walter, and Andreas Serra. "Comparing Blended Learning with Faculty-Led Ultrasound Training: Protocol for a Randomised Controlled Trial (The SIGNATURE Trial)." Praxis 109, no. 8 (June 2020): 636–40. http://dx.doi.org/10.1024/1661-8157/a003497.
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Abstract. Background: Ultrasound is increasingly used in clinical practice as a bedside tool. As medical graduates first encounter the technique in early residency, ultrasound training needs to be integrated into the undergraduate curriculum. In Switzerland, abdominal ultrasound skills have been taught by a faculty-led, 21-hour course. However, this course does not have sufficient capacity to meet the increasing demand, and there have been doubts about its effectiveness as a teaching method. We therefore developed a 21-hour blended-learning course, comprising five hours of e-learning and 16 hours of near-peer tutoring. This study investigates whether this new teaching format is as good as, or superior to, the faculty-led method. Methods: The SIGNATURE study is an investigator-initiated, two-arm, randomised controlled trial, enrolling 152 medical students at the Universities of Bern, Fribourg and Zurich. Stratified by study site, students are 1:1 randomised to either the blended-learning course or the faculty-led 2.5-day ultrasound course. Students undergo a six-station objective structured clinical examination (OSCE) and complete an online questionnaire immediately after the course and 6 months later. Discussion: If demonstrated to be effective, the blended-learning course would allow an increase in the number of undergraduate medical students that can acquire ultrasound skills before starting their residencies.
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Riedel, Robert G. "Effects of Pretrial Publicity on Male and Female Jurors and Judges in a Mock Rape Trial." Psychological Reports 73, no. 3_part_1 (December 1993): 819–32. http://dx.doi.org/10.1177/00332941930733pt117.
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A study explored influence of pretrial publicity and gender identity on verdicts and severity of sentence in a mock rape trial. Mock jurors and judges were exposed to four pretrial publicity conditions before watching a simulated rape trial. After viewing the trial, jurors rendered a verdict (guilty or not guilty) and judges prescribed a sentence. The Bern Sex-role Inventory was used to analyze gender identity and its relation to verdict and sentencing. Verdicts were not influenced by pretrial publicity, but sentencing was more severe following exposure of mock judges to pretrial publicity about a mistaken acquittal and less severe following exposure of these judges to pretrial publicity about a mistaken conviction. Subjects classified by the Bern inventory as feminine or androgynous rendered a verdict of “guilty” more often than subjects classified as masculine or undifferentiated. Men who rendered verdicts of “guilty” had less confidence in their judgments than men who found the defendant “not guilty.” Conversely, women who found the defendant “not guilty” expressed less confidence than women who found the defendant “guilty.” The findings are compared and contrasted with similar studies and discussed in regards to gender identity, subjects’ characteristics, and mode of presentation.
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Beilstein, Christian M., Gabija Krutkyte, Thomas Vetsch, Prisca Eser, Matthias Wilhelm, Zeno Stanga, Lia Bally, et al. "Multimodal prehabilitation for major surgery in elderly patients to lower complications: protocol of a randomised, prospective, multicentre, multidisciplinary trial (PREHABIL Trial)." BMJ Open 13, no. 1 (January 2023): e070253. http://dx.doi.org/10.1136/bmjopen-2022-070253.
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IntroductionThe global volume of surgery is growing and the population ageing, and economic pressure is rising. Major surgery is associated with relevant morbidity and mortality. Postoperative reduction in physiological and functional capacity is especially marked in the elderly, multimorbid patient with low fitness level, sarcopenia and malnutrition. Interventions aiming to optimise the patient prior to surgery (prehabilitation) may reduce postoperative complications and consequently reduce health costs.Methods and analysisThis is a multicentre, multidisciplinary, prospective, 2-arm parallel-group, randomised, controlled trial with blinded outcome assessment. Primary outcome is the Comprehensive Complications Index at 30 days. Within 3 years, we aim to include 2×233 patients with a proven fitness deficit undergoing major surgery to be randomised using a computer-generated random numbers and a minimisation technique. The study intervention consists of a structured, multimodal, multidisciplinary prehabilitation programme over 2–4 weeks addressing deficits in physical fitness and nutrition, diabetes control, correction of anaemia and smoking cessation versus standard of care.Ethics and disseminationThe PREHABIL trial has been approved by the responsible ethics committee (Kantonale Ethikkomission Bern, project ID 2020-01690). All participants provide written informed consent prior to participation. Participant recruitment began in February 2022 (10 and 8 patients analysed at time of submission), with anticipated completion in 2025. Publication of the results in peer-reviewed scientific journals are expected in late 2025.Trial registration numberNCT04461301.
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Amrein, Melanie Alexandra, Gian Giacomo Ruschetti, Carole Baeder, Melanie Bamert, and Jennifer Inauen. "Mobile intervention to promote correct hand hygiene at key times to prevent COVID-19 in the Swiss adult general population: study protocol of a multiphase optimisation strategy." BMJ Open 12, no. 3 (March 2022): e055971. http://dx.doi.org/10.1136/bmjopen-2021-055971.
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IntroductionBehaviour change is key to the public health measures that have been issued in many countries worldwide to contain COVID-19. Public health measures will only take preventive effect if people adhere to them. Interventions taking health psychology approaches may promote adherence to public health measures. However, evidence from randomised controlled behaviour change trials is scarce during an ongoing pandemic. We aim to use the example of hand washing with soap to optimise and test a digital, theory-based and evidence-based behaviour change intervention to prevent the spread of COVID-19.Methods and analysisThis protocol describes the multiphase optimisation strategy for the preparation, optimisation and evaluation of a theory-based and evidence-based intervention delivered via app. The app aims to promote correct hand hygiene at key times in the adult general population. The study will be conducted in German-speaking Switzerland. The preparation phase has identified relevant behavioural determinants of hand hygiene during a pandemic from health behaviour theories and formative research with focus groups (n=8). The optimisation phase will identify the most effective and acceptable combination and sequence of three intervention modules in a parallel randomised trial (n=387) with analysis of variance (ANOVA) and regression analysis. Additionally, thematic analysis of qualitative interview data (n=15) will be used to gain insights on the feasibility, usability and satisfaction of the intervention. The evaluation phase will test the optimised intervention against an active control group in a randomised controlled trial (n=205), analysing pre-post differences and 6-month follow-up effects with ANOVA and regression analysis.Ethics and disseminationThe trial was approved by the Cantonal Ethics Commission Bern of the Swiss Association of Research Ethics Committees (protocol ID: 2021-00164). Final results will be presented in peer-reviewed journals and at conferences.Trial registration numberNCT04830761.
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Zwahlen, Susanne, Monica Fliedner, and Steffen Eychmüller. "Overcoming recruitment challenges in a randomized clinical trial of early palliative care." Journal of Clinical Oncology 35, no. 31_suppl (November 1, 2017): 140. http://dx.doi.org/10.1200/jco.2017.35.31_suppl.140.
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140 Background: Reasons why clinical trials of early palliative care (ePC) interventions have prolonged patient recruitment time frames have been researched mainly qualitatively. Our objective was to identify major recruitment barriers encountered in our ePC trial, as well as to implement actions to overcome them. The impact of these changes on recruitment was measured. Methods: Data from all patients screened at the main study site (Inselspital, University Hospital Bern) between October 2013 and April 2016 were prospectively analyzed for: date of contact, reporting department, eligibility status, as well as consent status. Data until march 2014 was used to identify the main recruitment barriers. Starting in march 2014 changes to the recruitment process were implemented and all data from then onwards was used to estimate the impact of these adaptations. Results: The three main barriers identified were: Logistic, motivational, or related to eligibility criteria. Logistic barriers were overcome by changing from voluntary referral by the treating physician to systematically screening outpatient clinics of medical oncology, radio-oncology, gyneco-oncology and the internal medicine ward. Motivational barriers were addressed through education and dedicated study staff. Eligibility criteria were widened to include pancreatic and urothelial cancer. The actions implemented increased the accrual rate from one patient during a five month period to 2,8 patients per month. The widening of the eligibility criteria contributed to this result by recruiting 0,5 patients per month. The implementation of a systematic screening procedure increased the number of eligible patients invited to participate from one per month to 4,8 per month. An increase in the study consent rate from 20 % to 58 % can be translated into an increased acceptance of early palliative care. Conclusions: Education and dedicated study staff in order to increase the acceptance of ePC as well as a tool to identify eligible patients in a time-efficient manner improved patient recruitment in our ePC trial. We suggest that these factors can be relevant for the successful integration of ePC in standard oncology care.
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Theis, Susanne, Norman Bitterlich, Michael von Wolff, and Petra Stute. "Measuring Quality of Life: Incorporating Objectively Measurable Parameters within the Cross-Sectional Bern Cohort Study 2014 (BeCS-14)." International Journal of Environmental Research and Public Health 21, no. 1 (January 15, 2024): 94. http://dx.doi.org/10.3390/ijerph21010094.
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Up until now, the measurement of Quality of Life (QoL) was based on validated subjective rating tools rather than objective measurement. To become more independent of the self-assessment of probands, a way to objectively measure QoL should be found. A monocenter, cross-sectional, observational, non-interventional trial was performed from 2012 to 2014 at Inselspital Bern to evaluate the bio-functional status (BFS), a complex, generic, non-invasive, sex- and age-validated assessment tool, in a wide range of areas. A standardized battery of assessments was performed on 464 females and 166 males, ages 18 to 65 (n = 630). In addition to the survey of the BFS, participants replied—among others—to the validated questionnaire SF-36 for health-related QoL (n = 447, subgroup 1). Since the accepted cut-off value for BFA calculation is age ≥ 35 years, subgroup 2 included 227 subjects (all participants aged ≥ 35 years out of subgroup 1). In order to be able to compare the eight SF-36 subscales to BFS parameters, a comparable score set of single BFS items had to be constructed. Subsequently, we aimed to statistically identify BFS item combinations that best represented each SF-36 subscale. All eight SF-36 subscales were significantly represented by various different combinations of BFS items. A total of 24 single BFS items significantly correlated with SF-36 subscales, of which 15 were objective and nine were subjective. All eight SF-36 subscales were significantly represented by various different combinations of BFS items leading to stronger correlations (range five to nine BFS items), and overall, sex and age did not affect these associations, but in the SF-36 subscales ‘bodily pain’ (sex) and ‘role limitations due to physical health problems’ (age in men). To our knowledge, we are the first to correlate a validated set of 34 objective and 9 subjective parameters with subjectively evaluated SF-36 subscales. This first study on the objectifiability of the SF-36 questionnaire demonstrated that questions on quality of life can be answered independently of a subjective assessment by subjects in future scientific studies.
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Liechti, Fabian D., Jeannelle Heinzmann, Joachim M. Schmidt Leuenberger, Andreas Limacher, Maria M. Wertli, and Martin L. Verra. "Effect of goal-directed mobilisation intervention compared with standard care on physical activity among medical inpatients: protocol for the GoMob-in randomised controlled trial." BMJ Open 12, no. 5 (May 2022): e058509. http://dx.doi.org/10.1136/bmjopen-2021-058509.
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IntroductionDespite the fact that immobilisation is a major contributor to morbidity and mortality, patients hospitalised in general internal medicine (GIM) wards spend up to 50% of time in bed. Previous studies in selected patient populations showed increased mobility after implementation of goal-directed mobilisation (GDM). Due to the study design used so far, the degree of evidence is generally low. The effect of GDM on clinical outcomes and economically relevant indicators in patients hospitalised in GIM wards is currently unknown. This study aims to evaluate a GDM intervention compared to standard care on physical activity (de Morton Mobility Index, DEMMI) in medical inpatients.Methods and analysisGoMob-in is a randomised, controlled, open-label study with blinded outcome assessment. We plan to enrol 160 inpatients with indication for physiotherapy on GIM wards of a tertiary hospital in Bern, Switzerland. Adult patients newly hospitalised on GIM wards will be included in the study. The primary outcome will be the change in the DEMMI score between baseline and 5 days. Secondary outcomes are change of DEMMI (inclusion to hospital discharge), mobilisation time (inclusion to day 5, inclusion to discharge), in-hospital delirium episodes, number of in-hospital falls, length of stay, number of falls within 3 months, number of re-hospitalisations and all-cause mortality within 3 months, change in independence during activities of daily living, concerns of falling, and quality of life within 3 months and destination after 3 months. Patients in the intervention group will be attributed a regularly updated individual mobility goal level made visible for all stakeholders and get a short educational intervention on GDM.Ethics and disseminationThis study has been approved by the responsible Ethics Board (Ethikkommission Bern/2020–02305). Written informed consent will be obtained from participants before study inclusion. Results will be published in open access policy peer-reviewed journals.Trial registration numberNCT04760392.
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Adam, Luise, Elisavet Moutzouri, Christine Baumgartner, Axel Lennart Loewe, Martin Feller, Khadija M’Rabet-Bensalah, Nathalie Schwab, et al. "Rationale and design of OPtimising thERapy to prevent Avoidable hospital admissions in Multimorbid older people (OPERAM): a cluster randomised controlled trial." BMJ Open 9, no. 6 (June 2019): e026769. http://dx.doi.org/10.1136/bmjopen-2018-026769.
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Introduction Multimorbidity and polypharmacy are important risk factors for drug-related hospital admissions (DRAs). DRAs are often linked to prescribing problems (overprescribing and underprescribing), as well as non-adherence with drug regimens for different reasons. In this trial, we aim to assess whether a structured medication review compared with standard care can reduce DRAs in multimorbid older patients with polypharmacy. Methods and analysis OPtimising thERapy to prevent Avoidable hospital admissions in Multimorbid older people is a European multicentre, cluster randomised, controlled trial. Hospitalised patients ≥70 years with ≥3 chronic medical conditions and concurrent use of ≥5 chronic medications are included in the four participating study centres of Bern (Switzerland), Utrecht (The Netherlands), Brussels (Belgium) and Cork (Ireland). Patients treated by the same prescribing physician constitute a cluster, and clusters are randomised 1:1 to either standard care or Systematic Tool to Reduce Inappropriate Prescribing (STRIP) intervention with the help of a clinical decision support system, the STRIP Assistant. STRIP is a structured method performing customised medication reviews, based on Screening Tool of Older People’s Prescriptions/Screening Tool to Alert to Right Treatment criteria to detect potentially inappropriate prescribing. The primary endpoint is any DRA where the main reason or a contributory reason for the patient’s admission is caused by overtreatment or undertreatment, and/or inappropriate treatment. Secondary endpoints include number of any hospitalisations, all-cause mortality, number of falls, quality of life, degree of polypharmacy, activities of daily living, patient’s drug compliance, the number of significant drug–drug interactions, drug overuse and underuse and potentially inappropriate medication. Ethics and dissemination The local Ethics Committees in Switzerland, Ireland, The Netherlands and Belgium approved this trial protocol. We will publish the results of this trial in a peer-reviewed journal. Main funding European Union’s Horizon 2020 programme. Trial registration number NCT02986425, NCT000002183,NCT6012, U1111-1181-9400.
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Wertli, Maria M., Julian S. Flury, Sven Streit, Andreas Limacher, Vanessa Schuler, Asha-Naima Ferrante, Caroline Rimensberger, and Manuel Haschke. "Efficacy of metamizole versus ibuprofen and a short educational intervention versus standard care in acute and subacute low back pain: a study protocol of a randomised, multicentre, factorial trial (EMISI trial)." BMJ Open 11, no. 10 (October 2021): e048531. http://dx.doi.org/10.1136/bmjopen-2020-048531.
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IntroductionLow back pain (LBP) is among the top three most common diseases worldwide, resulting in a life with pain-related disability. To date, no study has assessed the efficacy of metamizole (dipyrone), a non-opioid analgesic and antipyretic prodrug compared with the conventional non-steroidal anti-inflammatory drug ibuprofen, in patients with an acute LBP episode. Further, it is unclear, whether a short educational intervention is superior to usual care alone.ObjectivesThe objective of this study is to assess first, whether metamizole is non-inferior to ibuprofen in a new episode of acute or subacute LBP. Second, we aim to assess whether a short educational intervention including evidence-based patient information on the nature of LBP is superior to usual care alone.Methods and analysisAn investigator-initiated multicentre, randomised, double blind trial using a factorial design will be performed. A total of 120 participants with a new episode of LBP will be recruited from GP practices, outpatient clinics and from emergency departments, and randomised into four different treatment groups: ibuprofen alone, ibuprofen and short intervention, metamizole alone, metamizole and short intervention. The primary endpoint for the medical treatment will be change in pain assessed on an 11-point Numeric Rating Scale after 14 days. The primary outcome for the short intervention will be change in the Core Outcome Measures Index assessed after 42 days.Ethics, dissemination and fundingThis study has been approved by the responsible Ethics Board (Ethikkommission Bern/2018-01986) and the Swiss Agency for Therapeutic Products (Swissmedic/2019DR4002). Results will be published in open access policy peer-reviewed journals. The study is funded by the Swiss National Science Foundation (grant number 32 003B-179346).Trial registration numberNCT04111315
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Mathier, Etienne, Alexander Althaus, Daniel Zwahlen, Jens Lustenberger, Constantinos Zamboglou, Berardino De Bari, Daniel M. Aebersold, Matthias Guckenberger, Thomas Zilli, and Mohamed Shelan. "HypoFocal SRT Trial: Ultra-hypofractionated focal salvage radiotherapy for isolated prostate bed recurrence after radical prostatectomy; single-arm phase II study; clinical trial protocol." BMJ Open 14, no. 1 (January 2024): e075846. http://dx.doi.org/10.1136/bmjopen-2023-075846.
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IntroductionDespite radical prostatectomy (RP) and radiotherapy (RT) being established treatments for localised prostate cancer, a significant number of patients experience recurrent disease. While conventionally fractionated RT is still being used as a standard treatment in the postoperative setting, ultra-hypofractionated RT has emerged as a viable option with encouraging results in patients with localised disease in the primary setting. In addition, recent technological advancements in RT delivery and precise definition of isolated macroscopic recurrence within the prostate bed using prostate-specific membrane antigen-positron emission tomography (PSMA-PET) and multiparametric MRI (mpMRI) allow the exploration of ultra-hypofractionated schedules in the salvage setting using five fractions.Methods and analysisIn this single-arm prospective phase II multicentre trial, 36 patients with node-negative prostate adenocarcinoma treated with RP at least 6 months before trial registration, tumour stage pT2a–3b, R0–1, pN0 or cN0 according to the UICC TNM 2009 and evidence of measurable local recurrence within the prostate bed detected by PSMA PET/CT and mpMRI within the last 3 months, will be included. The patients will undergo focal ultra-hypofractionated salvage RT with 34 Gy in five fractions every other day to the site of local recurrence in combination with 6 months of androgen deprivation therapy. The primary outcome of this study is biochemical relapse-free survival at 2 years. Secondary outcomes include acute side effects (until 90 days after the end of RT) of grade 3 or higher based on Common Terminology Criteria for Adverse Events V.5, progression-free survival, metastasis-free survival, late side effects and the quality of life (based on European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30, QLQ-PR25).Ethics and disseminationThe study has received ethical approval from the Ethics Commission of the Canton of Bern (KEK-BE 2022-01026). Academic dissemination will occur through publications and conference presentations.Trial registration numberNCT05746806.
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Jungo, Katharina Tabea, Zsofia Rozsnyai, Sophie Mantelli, Carmen Floriani, Axel Lennart Löwe, Fanny Lindemann, Nathalie Schwab, et al. "‘Optimising PharmacoTherapy In the multimorbid elderly in primary CAre’ (OPTICA) to improve medication appropriateness: study protocol of a cluster randomised controlled trial." BMJ Open 9, no. 9 (September 2019): e031080. http://dx.doi.org/10.1136/bmjopen-2019-031080.
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IntroductionMultimorbidity and polypharmacy are major risk factors for potentially inappropriate prescribing (eg, overprescribing and underprescribing), and systematic medication reviews are complex and time consuming. In this trial, the investigators aim to determine if a systematic software-based medication review improves medication appropriateness more than standard care in older, multimorbid patients with polypharmacy.Methods and analysisOptimising PharmacoTherapy In the multimorbid elderly in primary CAre is a cluster randomised controlled trial that will include outpatients from the Swiss primary care setting, aged ≥65 years with ≥three chronic medical conditions and concurrent use of ≥five chronic medications. Patients treated by the same general practitioner (GP) constitute a cluster, and clusters are randomised 1:1 to either a standard care sham intervention, in which the GP discusses with the patient if the medication list is complete, or a systematic medication review intervention based on the use of the 'Systematic Tool to Reduce Inappropriate Prescribing'-Assistant (STRIPA). STRIPA is a web-based clinical decision support system that helps customise medication reviews. It is based on the validated ‘Screening Tool of Older Person’s Prescriptions’ (STOPP) and ‘Screening Tool to Alert doctors to Right Treatment’ (START) criteria to detect potentially inappropriate prescribing. The trial’s follow-up period is 12 months. Outcomes will be assessed at baseline, 6 and 12 months. The primary endpoint is medication appropriateness, as measured jointly by the change in the Medication Appropriateness Index (MAI) and Assessment of Underutilisation (AOU). Secondary endpoints include the degree of polypharmacy, overprescribing and underprescribing, the number of falls and fractures, quality of life, the amount of formal and informal care received by patients, survival, patients’ quality adjusted life years, patients’ medical costs, cost-effectiveness of the intervention, percentage of recommendations accepted by GPs, percentage of recommendation rejected by GPs and patients’ willingness to have medications deprescribed.Ethics and disseminationThe ethics committee of the canton of Bern in Switzerland approved the trial protocol. The results of this trial will be published in a peer-reviewed journal.Main fundingSwiss National Science Foundation, National Research Programme (NRP 74) ‘Smarter Healthcare’.Trial registration numbersClinicaltrials.gov (NCT03724539), KOFAM (Swiss national portal) (SNCTP000003060), Universal Trial Number (U1111-1226-8013).
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Arifi, Deborah, Norman Bitterlich, Michael von Wolff, Dagmar Poethig, and Petra Stute. "Impact of chronic stress exposure on cognitive performance incorporating the active and healthy aging (AHA) concept within the cross-sectional Bern Cohort Study 2014 (BeCS-14)." Archives of Gynecology and Obstetrics 305, no. 4 (November 6, 2021): 1021–32. http://dx.doi.org/10.1007/s00404-021-06289-z.
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Abstract Purpose This study aims to verify that the mental-cognitive domain of the validated generic bio-functional status (BFS)/bio-functional age (BFA) assessment tool, incorporating the concept of Active and Healthy Ageing (AHA), reflects cognitive performance. In addition, the effects of chronic stress exposure on the mental-cognitive BFS/BFA should be investigated. Methods The study was carried out as a monocenter, cross-sectional, observational, non-interventional trial (Bern Cohort Study 2014, BeCS-14) with the participation of 147 non-pediatric, non-geriatric subjects. All participants followed a standardized battery of biopsychosocial assessments consisting of BFS/BFA, a validated cognitive performance test battery (Inventar zur Gedächtnisdiagnostik; IGD) and a validated questionnaire for the assessment of chronic stress (Trier Inventory for the assessment of Chronic Stress; TICS), respectively. Results Mean cognitive performance was average and higher in younger or better educated individuals. The BFA of the participants was 7.8 ± 7.8 year-equivalents below their chronological age. The mental-cognitive BFS/BFA assessment correlated well with the validated questionnaire for cognition assessment, the IGD. Further, three TICS subdomains (work overload (r = − 0.246, p = 0.003), work discontent (r = − 0.299, p = 0.006) and pressure to succeed (r = − 0.274, p < 0.001)), reflecting mainly work-related stress, showed a significant negative correlation with the mental-cognitive BFS/BFA. Conclusions Our study shows that the BFS/BFA assessment tool follows European Innovation Partnership on Active and Healthy Ageing (EIP-AHA) requirements. Further, we could demonstrate that higher levels of chronic work-related stress may be associated with poorer mental-cognitive performance and a pro-aging state indicating that cognitive impairments can be reduced by stress management interventions.
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Miloradova, N. E. "Scenario tendencies of professional genesis of investigators of pre-trial investigation agencies of the National police of Ukraine." Law and Safety 76, no. 1 (February 20, 2020): 153–51. http://dx.doi.org/10.32631/pb.2020.1.22.
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The author of the article has presented results of a thorough analysis of international (A. Adler, E. Bern, R. Brasington, T. Keller, C. Toich, S.B. Karpman, K. Steiner, etc.) and domestic (K. O. Abulkhanova-Slavska, O. O. Bodalov, Ye. I. Holovakha, E. F. Zeier, Ye. O. Klimov, N. S. Priazhnikova, Ye. Yu. Priazhnikov, S. L. Rubinshtein, E. E. Symaniuk, etc.) approaches to consider specific features of professional development of individuals and formation of scenario tendencies for self-deployment within personal and professional fields.
Based on the analysis of the works of the mentioned scholars the author has distinguished and substantiated the existence and has provided characteristics to five basic types of scenarios of professional genesis of investigators: rapidly growing (gradual increase of indicators of all basic psychological characteristics); growing (increase in indicators of one or two basic psychological characteristics); averaged (absence of changes in indicators of basic psychological characteristics, presence of average indicators of basic psychological characteristics); decreasing (decrease in indicators of one or two basic psychological characteristics) and rapidly decreasing (gradual decrease in indicators of all basic psychological characteristics). It has been stated that it is possible to distinguish within each of these scenarios, variants of the scenario depending on the level of manifestation of indicators of the basic psychological characteristics of professional genesis.
The list of possible advantages and risks of the development of the scenarios of professional genesis of investigators has been determined. The advantages and risks are related to both external and internal factors. It has been emphasized that it is necessary to pay attention to the fact that the transition from one stage to another and from stage to stage within the stage can produce changes in their characteristics while analyzing scenario tendencies of the employees of investigative units.
It has been noted that the study of professional genesis of investigators starting from the stage of conscious choice of the professional path up to the moment of dismissal from the National Police through the prism of scenario approach makes it possible to comprehensively analyze professional self-deployment of individuals through the analysis of the correlation and mutual interaction of indicators of the basic psychological characteristics and conditions of the professional environment within each of the stages.
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Klukowska-Röetzler, Jolanta, Maria Eracleous, Martin Müller, David Srivastava, Gert Krummrey, Osnat Keidar, and Aristomenis Exadaktylos. "Increased Urgent Care Center Visits by Southeast European Migrants: A Retrospective, Controlled Trial from Switzerland." International Journal of Environmental Research and Public Health 15, no. 9 (August 28, 2018): 1857. http://dx.doi.org/10.3390/ijerph15091857.
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We investigated whether immigrants from Southeast Europe (SE) and Swiss patients have different reasons for visiting the emergency department (ED). Our retrospective data analysis for the years 2013–2017 describes the pattern of ED consultations for immigrants from SE living in Switzerland (Canton Bern), in comparison with Swiss nationals, with a focus on type of referral and reason for admission. A total of 153,320 Swiss citizens and 12,852 immigrants from SE were included in the study. The mean age was 51.30 (SD = 21.13) years for the Swiss patients and 39.70 (SD = 15.87) years for the SE patients. For some countries of origin (Albania, Bosnia and Herzegovina, and Turkey), there were highly statistically significant differences in sex distribution, with a predominance of males. SE immigrants had a greater proportion of patients in the lower triage level (level 3: SE: 67.3% vs. Swiss: 56.0%) and a greater proportion of patients in the high triage level than the Swiss population (level 1: SE: 3.4% vs. Swiss: 8.8%). SE patients of working age (16–65 years) were six times more often admitted by ambulance than older (≥65 years) SE patients, whereas this ratio was similar in the Swiss population. In both groups, the fast track service was primarily used for patients of working age (<65) and more than three times more often in the SE than the Swiss group (SE: 39.1%, Swiss: 12.6%). We identified some indications for access to primary care in emergency departments for immigrants and highlighted the need for attention to the role of organizational characteristics of primary health care in Switzerland. We highlighted the need for professional support to improve the quality of healthcare for immigrants. In the future, we will need more primary care services and general practitioners with a migrant background.
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Pimentel, Leonardo Duarte, Claudio Horst Bruckner, Candida Elisa Manfio, Sérgio Yoshimitsu Motoike, and Hermínia Emília Prieto Martinez. "SUBSTRATE, LIME, PHOSPHORUS AND TOPDRESS FERTILIZATION IN MACAW PALM SEEDLING PRODUCTION." Revista Árvore 40, no. 2 (April 2016): 235–44. http://dx.doi.org/10.1590/0100-67622016000200006.
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ABSTRACT The macaw palm [Acrocomia aculeata (Jacq.) Lood. ex Mart] has been domesticated to subsidize biodiesel production programs in Brazil. However, little is known about the seedling production of this species. This study aimed to evaluate substrate mixtures, limestone and phosphorus rates for substrate amendment and topdressing frequency in macaw palm seedlings. Three trials were conducted in a greenhouse up to six months of nursery cultivation. Trial 1: determination of percent mineral and organic fractions of seven substrate mixtures. Trial 2: evaluation of four limerates for soil amendment versus four phosphorus rates. Trial 3: evaluation of N, K and Mg topdressing frequency. Significant differences were found in the three trials for most of the variables (plant height, leaf number, shoot dry mass, root dry mass, vigor and bulb diameter). The main results obtained were as follow: Trial1 - the best seedling growth was observed in substrates with at least 25% organic matter. Trial2 -lime rates ranging from 0.50 to 1.25 kg associated with 3 to 4 kg of single superphosphate per m3 of substrate provided the best seedling growth. Trial 3 - topdressing fertilization provided better development of seedlings regardless of frequency.
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Theiler, Lorenz, Fabian Schneeberg, Thomas Riedel, Heiko Kaiser, Thomas Riva, and Robert Greif. "Apnoeic oxygenation with nasal cannula oxygen at different flow rates in anaesthetised patients: a study protocol for a non-inferiority randomised controlled trial." BMJ Open 9, no. 7 (July 2019): e025442. http://dx.doi.org/10.1136/bmjopen-2018-025442.
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IntroductionApnoeic oxygenation using nasal high-flow oxygen delivery systems with heated and humidified oxygen has recently gained popularity in the anaesthesia community. It has been shown to allow a prolonged apnoea time of up to 65 min as CO2increase was far slower compared with previously reported data from CO2increase during apnoea. A ventilatory exchange due to the high nasal oxygen flow was proposed explaining that phenomenon. However, recent studies in children did not show any difference in CO2clearance comparing high-flow with low-flow oxygen. To investigate this ventilatory exchange in adults, we plan this study comparing different oxygen flow rates and the increase of CO2during apnoea. We hypothesise that CO2clearance is non-inferior when applying low oxygen flow rates.Methods and analysisIn this single-centre, single-blinded, randomised controlled trial, we randomly assign 100 patients planned for elective surgery to either control (oxygen 70 L/min, airway opened by laryngoscopy) or one of three intervention groups: oxygen 70, or 10, or 2 L/min, all with jaw thrust to secure airway patency. After anaesthesia induction and neuromuscular blockage, either one of the interventions or the control will be applied according to randomisation. Throughout the apnoea period, we will measure the increase of transcutaneous pCO2(tcpCO2) until any one of the following criteria is met: time=15 min, SpO2<92%, tcpCO2>10.67 kPa, art. pH <7.1, K+>6.0 mmol/L. Primary outcome is the mean tcpCO2increase in kPa/min.Ethics and disseminationAfter Cantonal Ethic Committee of Bern approval (ID 2018–00293, 22.03.2018), all study participants will provide written informed consent. Patients vulnerable towards hypoxia or hypercarbia are excluded. Study results will be published in a peer-reviewed journal and presented at national and international conferences.Trial registration numberThis study was registered onwww.clinicaltrials.gov(NCT03478774,Pre-results) and the Swiss Trial Registry KOFAM (SNCTP000002861).
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Uslu, Arif Sinan, Stephan M. Gerber, Nadine Schmidt, Carina Röthlisberger, Patric Wyss, Tim Vanbellingen, Sandra Schaller, et al. "Investigating a new tablet-based telerehabilitation app in patients with aphasia: a randomised, controlled, evaluator-blinded, multicentre trial protocol." BMJ Open 10, no. 11 (November 2020): e037702. http://dx.doi.org/10.1136/bmjopen-2020-037702.
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IntroductionAphasia is a common language disorder acquired after stroke that reduces the quality of life of affected patients. The impairment is frequently accompanied by a deficit in cognitive functions. The state-of-the-art therapy is speech and language therapy but recent findings highlight positive effects of high-frequency therapy. Telerehabilitation has the potential to enable high-frequency therapy for patients at home. This study investigates the effects of high-frequency telerehabilitation speech and language therapy (teleSLT) on language functions in outpatients with aphasia compared with telerehabilitative cognitive training. We hypothesise that patients training with high-frequency teleSLT will show higher improvement in language functions and quality of life compared with patients with high-frequency tele-rehabilitative cognitive training (teleCT).Methods and analysisThis study is a randomised controlled, evaluator-blinded multicentre superiority trial comparing the outcomes following either high-frequency teleSLT or teleCT. A total of 100 outpatients with aphasia will be recruited and assigned in a 1:1 ratio stratified by trial site and severity of impairment to one of two parallel groups. Both groups will train over a period of 4 weeks for 2 hours per day. Patients in the experimental condition will devote 80% of their training time to teleSLT and the remaining 20% (24 min/day) to teleCT, vice versa for patients in the control condition. The primary outcome measure is the understandability of verbal communication on the Amsterdam Nijmegen Everyday Language Test and secondary outcome measures are intelligibility of the verbal communication, impairment of receptive and expressive language functions, confrontation naming. Other outcomes measures are quality of life and acceptance (usability and subjective experience) of the teleSLT system.Ethics and disseminationThis study is approved by the Ethics Committee Bern (ID 2016-01577). Results will be submitted to a peer-reviewed journal.Trial registration numberNCT03228264.
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Stawarska-Rippel, Anna. "Kontradyktoryjność i inkwizycyjność w europejskiej procedurze cywilnej XIX i XX wieku." Czasopismo Prawno-Historyczne 65, no. 2 (October 31, 2018): 123–44. http://dx.doi.org/10.14746/cph.2013.65.2.05.
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Socialisation of private law in the second half of the 19th century brought about a new approach to a civil process and its purpose. The main characteristics of the evolution of the civil procedure in the 19th and 20th centuries was limited autonomy of the parties to a process. This limitation was introduced to ensure fair, expedient and cost-effective judgment. A tendency to replace the principle of an adversarial trial with elements of an inquisitorial trial was observed in civil law as well as common law systems. Relevant changes were fi rst made in the Franz Klein Austrian code of civil procedure, followed by departures from the formal truth in the civil process implemented in the system in Germany, Hungary, the Swiss cantons of Zurich and Bern, in Poland, and later, in the second half of the 20th century, also in France. In the common law system, the reform of 1999 ascertained judges a number of discretionary powers to help them establish the facts in a civil proceeding. Those changes added the public element in the civil procedure, but the very idea of a private process and the protection of private interests has been maintained. The totalitarian regimes which emerged in some European states considerably distorted the process of shaping the relationship between the state and the individual. In the socialist civil proceeding, the principle ne eat iudex ultra petita partium was replaced with ex offi cio ultra petita, which was a novelty characteristic of the civil procedure of totalitarian states. The departure from an adversarial principle in the socialist civil process was not much different from the general tendencies observed in the civil procedure in West European states. After the political transformations and change of the regime, former states of the Eastern Bloc sought to signifi cantly increase the autonomy of the parties in a civil process. However, as experience of the Western European states shows, certain public elements must be taken into account in a civil procedure if the European Convention on Human Rights is to be observed.
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Miklas, Phillip N., and Jose Santiago. "Reaction of Select Tepary Bean to Bean Golden Mosaic Virus." HortScience 31, no. 3 (June 1996): 430–32. http://dx.doi.org/10.21273/hortsci.31.3.430.
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Cultivated tepary bean (Phaseolus acutifolius A. Gray var. latifolius Freeman) has potential for production during the hot, dry seasons in the tropics. Bean golden mosaic virus (BGMV), however, seriously limits production of Phaseolus spp. in such environments. Twelve select tepary beans were evaluated for reaction to BGMV across four field nurseries near Isabela, Puerto Rico. Disease reaction was principally determined by measurement of seed yield (kg·ha–1) and weight (g 100/seeds). All tepary beans possessed some tolerance to BGMV, as they produced comparatively moderate seed yield despite expression of severe foliar yellow mosaic symptoms. On average, tepary bean yielded 133% of the BGMV-resistant dry bean (Phaseolus vulgaris L.) control `Dorado'. Four teparies, Neb-T-6-s, GN-610-s, Neb-T-8a-s, and PI 321637-s, expressed superior tolerance to BGMV as they yielded above the trial mean in at least three of four trials. Harvested seed quality was uniformly poor across all lines, averaging 18% less weight than in the non-BGMV trials. The combination of the observed tolerance with escape mechanisms and cultural disease control practices may enable production of tepary bean in regions and seasons that experience moderate to severe BGMV epidemics.
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Kiosak, Dmytro, and Zhanna Matviishyna. "The Soils of Early Farmers and Their Neighbors in the Southern Buh Catchment (Ukraine): Micromorphology and Archaeological Context." Land 12, no. 2 (January 31, 2023): 388. http://dx.doi.org/10.3390/land12020388.
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The problems regarding hunter-gatherer/early farmer interactions are quite an important topic in southeast European archaeology. According to the available data, the two economic subsistence systems have coexisted for some 2000 years during the 6th–4th millennia cal BC (Telegin 1985; Lillie et al., 2001). In some areas, hunter-gatherer and early farmer sites are located just a few kilometers apart. The Southern Buh River valley has yielded evidence of Linear Pottery culture, early Trypillia and Trypillia B1 Neolithic settlements as well as hunter-gatherer sites with pottery attributable to the so-called sub-Neolithic or para-Neolithic (Haskevych et al., 2019; Kiosak et al., 2021). Trial-trenches have been opened within some of these sites, which have been radiocarbon-dated from Bern University laboratory (LARA). Soil samples for micromorphological analysis have been collected from these sites to interpret their paleogenetic formation. The soil development is attested since, at least, the beginning of the 5th mill BC, followed by the developed of chernozem soils, which was interrupted by an erosional episode in the end of 5th millennium BC. The available data show that the soils of early farmers arable as are the present day ones. The early farmers were able to exploit relatively heavy soils to cultivate wheat and barley as early as 5250–5050 cal BC. In contrast, the sites of ceramic hunter-gatherers were often located on the soils which formed under wet conditions along seasonally flooded riverbanks, which were almost unsuitable for agricultural practices.
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Phuong, Tran Vinh, Nguyen Anh Tuan, Nguyen Duy Thuan, Ngo Thi Huong Giang, Tran Nguyen Ngoc, Nguyen Duy Quynh Tram, and Nguyen Quang Linh. "Effects of protein levels of commercial diets on the growth performance and survival rate of rabbitfish (Siganus guttatus) at the nursing stage." Journal of Experimental Biology and Agricultural Sciences 10, no. 5 (October 31, 2022): 1115–20. http://dx.doi.org/10.18006/2022.10(5).1115.1120.
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This study aimed to determine the effect of a commercial diet's protein level on the fry-to-fingerling stage. Thirty days-old fries having the initial length and weight of 18.25 ± 0.15 mm fish-1 and 0.036 ± 0.50 g fish-1 respectively have been used in this study. Diet having three protein levels i.e. 30% (trial 1 as control), 35% (trial 2), 40% (trial 3), and 45% (trial 4), respectively, have been used to evaluate the effect of protein, and each trial has been repeated three times. During the study, stocking density was allocated to 1000 fish per composite tank with a volume of 1 m3. After 30 days of rearing, the weight of fingerlings in trial 1 reached up to 1.50 ± 0.02 g fish-1 and it was recorded as 1.52 ± 0.01g for trial 2, these two were lower than that of trials 3 and 4, where fingerling weight was reported 1.69 ± 0.01 and 1.58g fish-1 respectively and obtained the best weight compared to others. The length of fingerlings at the end of the experimental period was also changed in different trials and it was recorded 47.12; 46.92; 50.97; and 48.89 mm fish-1 for trail 1, 2, 3, and 4 respectively, among the tested combinations lower fingerlings length was recorded for trial 2 (35% CP), but it is not significantly different for trial 1 and 2 and a significant difference (P < 0.05) was reported for trail 2, 3, and 4. The survival rate of fingerlings ranged from 67.27 to 72.33%. Meanwhile, the herd distribution coefficient variation (CVW) in the treatment using 40% protein (trial 3) was the highest at 72.33% (p < 0.05). The results of the study can be concluded that the level of protein has a significant effect on the various growth parameters of fingerlings.
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Christ, L., A. Gloor, F. Kollert, S. Reichenbach, and P. Villiger. "POS0265 SERUM PROTEOMICS IN GIANT CELL ARTERITIS IN RESPONSE TO A THREE-DAY PULSE OF GLUCOCORTICOID FOLLOWED BY TOCILIZUMAB MONOTHERAPY (THE GUSTO TRIAL)." Annals of the Rheumatic Diseases 81, Suppl 1 (May 23, 2022): 374.2–375. http://dx.doi.org/10.1136/annrheumdis-2022-eular.434.
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BackgroundMeasuring disease activity in Giant Cell Arteritis (GCA) remains a challenge, particularly, if Tocilizumab (TCZ) is prescribed which blunts the acute phase response. A proteome analysis may not only serve to identify biomarkers, but also to shed light on pathophysiology. The sequential administration of Glucocorticoids (GC) and TCZ as done in the GUSTO study (GCA treatment with ultra-short GC and TCZ) provides a unique opportunity to dissect the effects of GC and TCZ.ObjectivesTo investigate the effects of pulse GC-treatment and of ensuing long-term TCZ monotherapy on serum proteins in GCA; to compare the serological findings with clinical response; to search for proteins which are not under control of IL-6 and may be suitable as biomarkers of disease activity.MethodsEighteen patients with newly diagnosed GCA received 500 mg methylprednisolone intravenously for 3 consecutive days (NCT03745586). Thereafter, GC treatment was discontinued and a single dose of TCZ (8 mg/kg body-weight) was administered intravenously, followed by weekly subcutaneous TCZ injections (162 mg) from day 10 until week 52. Serum samples were collected prior to treatment (day 0), at day 3 (after GC treatment), day 10 and at weeks 4, 24, and 52 (Lancet Rheumatology, https://doi.org/10.1016/S2665-9913(21)00152-1). Sera of patients were analyzed on Olink Explore 1536, capturing over 1400 proteins. Protein wise t-tests (threshold, adjusted p-value < 0.05) with adjustment for multiple testing (Benjamini-Hochberg) were performed to identify differentially expressed proteins (DEPs) between day 0 vs day 3 (referred to as GC treatment) and day 0 vs week 52 (referred to as TCZ treatment, remission). DEPs were grouped in pathways identified in the KEGG database.ResultsSuccessful treatment resulted in the upregulation of 254 proteins and the downregulation of 245 proteins from day 0 to week 52. Protein levels did not change between week 24 and 52 during established full remission.In response to GC pulse therapy the ten most significant DEPs included ANGPTL7, AREG, IL1RL1, MATN3, MMP3, SPARCL1 (upregulated) and IL12A, IL12B, KLK10, SIGLEC6 (downregulated). Conversely, under treatment with TCZ, SIGLEC6 was continuously up- and MMP3 and AREG were continuously down-regulated from day 3 to week 4.KEGG pathways of interest in GCA (day 0 vs day 3 and day 0 vs week 52, respectively) included: cytokine-cytokine receptor interaction, the PI3K-AKT, JAK-STAT, IL17, TNF, NF-kappa B, Toll-like receptor and MAPK signaling pathways. Figure 1 displays the top 5 KEGG pathways enriched in TCZ-treated GCA patients in remission.Figure 1.Network plot of the top 5 KEGG pathways from day 0 vs week 52. Size in the figure legend refers to the number of proteins in each pathway. Estimate in the figure legend indicates the log2 fold change from day 0 vs week 52.ConclusionOne third of the measured proteins covering a wide spectrum of pathways changed in response to pulse GC-treatment followed by TCZ monotherapy. Several proteins were inversely induced by GC or TCZ. Osteopontin, CSF1 and CCL18 as markers of macrophage activation should be explored as biomarkers of disease activity in TCZ-treated GCA-patients.AcknowledgementsThe study was funded in 50% by the Research Funds of the Department of Rheumatology, Immunology and Allergology, University Hospital and University of Bern, Bern, Switzerland, and 50% by F Hoffmann-La Roche.Disclosure of InterestsLisa Christ Shareholder of: Gilead Sciences and F. Hoffmann-La Roche Ltd, Consultant of: Bristol-Myers Squibb, Novartis, and Sanofi, Grant/research support from: Gilead Sciences, F. Hoffmann-La Roche Ltd, and Pfizer, Andrea Gloor: None declared, Florian Kollert Shareholder of: Roche, Consultant of: BMS, Actelion, Boehringer-Ingelheim, Pfizer, Grant/research support from: Roche, Gilead, Pfizer, Employee of: Roche, Stephan Reichenbach: None declared, Peter Villiger Speakers bureau: Roche, MSD, AbbVie, Pfizer, Novartis, Grünenthal, Amgen, Sanofi, Chugai, BMS, and Gilead, Consultant of: Advisory fees from Roche, MSD, AbbVie, Pfizer, Novartis, Grünenthal, Amgen, Sanofi, Chugai, BMS, and Gilead, Grant/research support from: Research support from Roche, MSD, AbbVie, and Pfizer
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Gutersohn, Caterina, Sandra Schweingruber, Maximilian Haudenschild, Markus Huber, Robert Greif, and Alexander Fuchs. "Medical device education: study protocol for a randomised controlled trial comparing self-directed learning with traditional instructor-led learning on an anaesthesia workstation." BMJ Open 13, no. 9 (September 2023): e070261. http://dx.doi.org/10.1136/bmjopen-2022-070261.
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IntroductionContinuous professional development is essential for maintaining competencies in healthcare. This applies to medical device knowledge and safe handling, which are fundamental for patient safety. Little is known about the efficiency of self-directed learning with an integrated video in medical device education. This study investigates whether anaesthesia providers acquire their medical device competencies on an anaesthesia workstation differently via self-directed learning than traditional teacher-led workshops.Methods and analysisThis single-centre, non-inferiority, randomised, controlled trial aims to enrol at least 224 anaesthesia providers (ie, certified nurses and physicians). Participants will be randomised to (1) self-directed learning with an integrated learning video (intervention) or (2) a traditional teacher-led workshop (control), for a 1-hour session on a new anaesthesia workstation. The two educational approaches and their effect on medical device competence will be assessed concerning 12 competencies in the same 10 min, objective, structured, clinical examination-like station for both groups. The primary endpoint will be an assessment score of ≥60%. Non-inferiority will be declared if the upper limit of a 90% two-sided CI excludes a difference of more than 10% in favour of the control group. Secondary endpoints will be: (1) the score achieved in the study assessment, (2) the number of open questions after the training, (3) training time in minutes, (4) use of resources and (5) costs, all of which are compared between both groups.Ethics and disseminationStudy participants will provide written informed consent. All recorded data will be stored on a password-protected research server at the study site accessible only to the investigators. The Bern Cantonal Ethics Committee waived the need for ethical approval (Req-2021–00837; 25 July 2021). There are no ethical, legal or security issues regarding data collection, processing, storage or dissemination.Trial registration numberNCT05530382, 7 September 2022; ClinicalTrials.gov
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Senn, H. J., R. Maibach, M. Castiglione, W. F. Jungi, F. Cavalli, S. Leyvraz, J. P. Obrecht, O. Schildknecht, and P. Siegenthaler. "Adjuvant chemotherapy in operable breast cancer: cyclophosphamide, methotrexate, and fluorouracil versus chlorambucil, methotrexate, and fluorouracil--11-year results of Swiss Group for Clinical Cancer Research trial SAKK 27/82." Journal of Clinical Oncology 15, no. 7 (July 1997): 2502–9. http://dx.doi.org/10.1200/jco.1997.15.7.2502.
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PURPOSE To compare two adjuvant combination chemotherapies, cyclophosphamide, methotrexate, and fluorouracil (CMF) and chlorambucil, methotrexate, and fluorouracil (LMF), for patients who had undergone potentially curative surgery for unilateral breast cancer, in terms of relapse, survival, and toxicity. PATIENTS AND METHODS Selection criteria was as follows: stage pT1-3a, N+ or N-, M0, less than 72 years of age. Eligible patients were randomized to receive either CMF (cyclophosphamide 100 mg/m2 orally on days 1 to 14, methotrexate 40 mg/m2 intravenously (I.V.) on days 1 and 8, fluorouracil 600 mg/m2 I.V. on days 1 and 8) or LMF (Leukeran [Wellcome A.G., Bern, Switzerland] 5 mg/m2 orally on days 1 to 14 with the some I.V. cytostatic drugs). Follow-up examinations were performed every 3 months during the first 3 years after mastectomy, and every 6 months thereafter. RESULTS A total of 246 patients were randomized, of whom 232 who were fully eligible and contribute to the analyses presented here. No statistically significant difference in favor of adjuvant CMF over LMF emerges after a median follow-up duration of 11.2 years, for either overall survival (P = .15) or disease-free survival (P = .14). A consistent trend suggestive of a possible relative benefit associated with CMF should be pointed out. However, CMF presents a significantly worse toxicity profile as concerns hematologic parameters as well as alopecia, nausea, and vomiting. CONCLUSION This prospective trial has not identified a statistically significant difference in disease-free survival or overall survival between the two adjuvant regimens LMF and CMF. Although a trend in favor of CMF has been observed in premenopausal patients, this has to be weighted against its definitely more pronounced toxicity profile.
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Ferreira, Antonio, Ahmed Fahiem Abdelsalam Emara, David Herzig, Andreas Melmer, Andreas P. Vogt, Christos T. Nakas, Andrea Facchinetti, Chiara Dalla Man, and Lia Bally. "Study protocol for a randomised, double-blind, placebo-controlled crossover trial assessing the impact of the SGLT2 inhibitor empagliflozin on postprandial hypoglycaemia after gastric bypass." BMJ Open 12, no. 9 (September 2022): e060668. http://dx.doi.org/10.1136/bmjopen-2021-060668.
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IntroductionPostprandial hypoglycaemia after gastric bypass surgery (also known as postbariatric hypoglycaemia or PBH) is an increasingly encountered clinical problem. PBH is characterised by meal-induced rapid spikes and consequent falls in glycaemia, resulting in both hypoglycaemia burden and high glycaemic variability. Despite its frequency, there is currently no approved pharmacotherapy. The purpose of this investigation is to evaluate efficacy and safety of empagliflozin 25 mg, a sodium-glucose cotransporter 2-inhibitor, to reduce glucose excursions and hypoglycaemia burden in patients with PBH after gastric bypass surgery.Methods and analysisIn a prospective, single-centre, randomised, double-blind, placebo-controlled, crossover trial, we plan to enrol 22 adults (≥18 years) with PBH after Roux-en-Y gastric bypass surgery (plasma or sensor glucose <3.0 mmol/L). Eligible patients will be randomised to receive empagliflozin 25 mg and placebo once daily, each for 20 days, in random order. Study periods will be separated by a 2–6 weeks wash-out period. The primary efficacy outcome will be the amplitude of plasma glucose excursion (peak to nadir) during a mixed meal tolerance test. Results will be presented as paired-differences±SD plus 95% CIs with p values and hypothesis testing for primary and secondary outcomes according to intention-to-treat. Secondary outcomes include continuous glucose monitoring-based outcomes, further metabolic measures and safety.Ethics and disseminationThe DEEP-EMPA trial (original protocol title: Randomized, double-blind, placebo-controlled crossover trialassessing the impact of the SGLT2 inhibitor empagliflozin onpostprandial hypoglycaemia after gastric bypass) was approved by the Bern Ethics Committee (ID 2021-01187) and Swissmedic (Ref. Number: 102663190) in October and November 2021, respectively. First results are expected in the first quarter of 2023 and will be disseminated via peer-reviewed publications and presented at national and international conferences. The acronym DEEP was derived from an overarching project title (DEciphering the Enigma of Postprandial Hyperinsulinaemic Hypoglycaemia after Bariatric Surgery), the term EMPA stands for the drug empagliflozin.Trial registration numberNCT05057819.
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Meier, Bernhard. "Closing the Patent Foramen Ovale with Amplatzer Devices." European Cardiology Review 5, no. 1 (2009): 71. http://dx.doi.org/10.15420/ecr.2009.5.1.71.
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The relative risk of a thromboembolic event is four-fold higher in the 25–35% of adults with a patent foramen ovale (PFO) and 33-fold higher in patients who also have an atrial septal aneurysm. The American PICSS trial showed a yearly incidence of stroke or death after an initial event of 5% with warfarin and 9% with acetylsalicylic acid. The presence of a PFO more than doubles the mortality rate in patients with clinically relevant pulmonary embolism. The risk of a PFO increases with age. Proof of effectiveness in migraine alleviation is likely to be achievable in a couple of years – much quicker than in prevention of paradoxical embolism. Percutaneous closure of PFO has been performed with various devices at the University Hospital Bern in Switzerland since April 1994, with over 1,000 patients treated. At the last available transoesophageal echocardiogram, a significant residual shunt persisted in 4% with Amplatzer devices and 17% with other devices. During follow-up, a recurrent embolic event was observed in 1.6% of patients per year – less than would be expected under medical treatment. Several randomised multicentre trials comparing catheter closure with medical treatment have been started. The PC and CLOSURE trials are in the follow-up phase; results cannot be expected before 2010, and they may well be ‘falsely’ neutral because the follow-up is rather short for the low-risk patients randomised. In a matched control study on patients with cryptogenic stroke and a PFO, 158 patients were treated medically and 150 concomitant patients underwent percutaneous PFO closure. At four years, PFO closure resulted in a trend towards risk reduction of death, stroke or transient ischaemic attack (TIA) (9 versus 24%; p=0.08) compared with medical treatment. The calculated occurrence of patients with cryptogenic strokes associated with a PFO amounts to somewhere between 100 and 300 per year and per million population, corresponding to more than 10% of yearly coronary angioplasty cases. Coronary and peripheral paradoxical emboli without prior exclusion of competing causes plus the presumed associations between PFO and migraine or decompression illness in divers open additional vast fields of potential indications for catheter closure. Finally, the linearly decreasing prevalence of a PFO with age suggests a weeding out of PFO carriers (unless spontaneous closure is assumed). A PFO represents a lethal threat that increases with age. It can be closed percutaneously in 15 minutes virtually free of complications. The patient can resume unrestricted physical activities a few hours after the intervention.
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Wittneben, J. G., J. Gavric, U. C. Belser, M. M. Bornstein, T. Joda, V. Chappuis, I. Sailer, and U. Brägger. "Esthetic and Clinical Performance of Implant-Supported All-Ceramic Crowns Made with Prefabricated or CAD/CAM Zirconia Abutments: A Randomized, Multicenter Clinical Trial." Journal of Dental Research 96, no. 2 (December 7, 2016): 163–70. http://dx.doi.org/10.1177/0022034516681767.
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Patients’ esthetic expectations are increasing, and the options of the prosthetic pathways are currently evolving. The objective of this randomized multicenter clinical trial was to assess and compare the esthetic outcome and clinical performance of anterior maxillary all-ceramic implant crowns (ICs) based either on prefabricated zirconia abutments veneered with pressed ceramics or on CAD/CAM zirconia abutments veneered with hand buildup technique. The null hypothesis was that there is no statistically significant difference between the 2 groups. Forty implants were inserted in sites 14 to 24 (FDI) in 40 patients in 2 centers, the Universities of Bern and Geneva, Switzerland. After final impression, 20 patients were randomized into group A, restored with a 1-piece screw-retained single crown made of a prefabricated zirconia abutment with pressed ceramic as the veneering material using the cut-back technique, or group B using an individualized CAD/CAM zirconia abutment (CARES abutment; Institut Straumann AG) with a hand buildup technique. At baseline, 6 mo, and 1 y clinical, esthetic and radiographic parameters were assessed. Group A exhibited 1 dropout patient and 1 failure, resulting in a survival rate of 94.7% after 1 y, in comparison to 100% for group B. No other complications occurred. Clinical parameters presented stable and healthy peri-implant soft tissues. Overall, no or only minimal crestal bone changes were observed with a mean DIB (distance from the implant shoulder to the first bone-to-implant contact) of −0.15 mm (group A) and 0.12 mm (group B) at 1 y. There were no significant differences at baseline, 6 mo, and 1 y for DIB values between the 2 groups. Pink esthetic score (PES) and white esthetic score (WES) values at all 3 examinations indicated stability over time for both groups and pleasing esthetic outcomes. Both implant-supported prosthetic pathways represent a valuable treatment option for the restoration of single ICs in the anterior maxilla ( ClinicalTrials.gov NCT02905838).
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Schindera, Christina, Claudia Elisabeth Kuehni, Mladen Pavlovic, Eva Simona Haegler-Laube, Daniel Rhyner, Nicolas Waespe, Jochen Roessler, Thomas Suter, and Nicolas Xavier von der Weid. "Diagnosing Preclinical Cardiac Dysfunction in Swiss Childhood Cancer Survivors: Protocol for a Single-Center Cohort Study." JMIR Research Protocols 9, no. 6 (June 10, 2020): e17724. http://dx.doi.org/10.2196/17724.
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Background Cardiovascular disease is the leading nonmalignant cause of late deaths in childhood cancer survivors. Cardiovascular disease and cardiac dysfunction can remain asymptomatic for many years, but eventually lead to progressive disease with high morbidity and mortality. Early detection and intervention are therefore crucial to improve outcomes. Objective In our study, we aim to assess the prevalence of preclinical cardiac dysfunction in adult childhood cancer survivors using conventional and speckle tracking echocardiography; determine the association between cardiac dysfunction and treatment-related risk factors (anthracyclines, alkylating agents, steroids, cardiac radiation) and modifiable cardiovascular risk factors (abdominal obesity, hypertension); investigate the development of cardiac dysfunction longitudinally in a defined cohort; study the association between cardiac dysfunction and other health outcomes like pulmonary disease, endocrine disease, renal disease, quality of life, fatigue, strength and endurance, and physical activity; and gain experience conducting a clinical study of childhood cancer survivors that will be extended to a national, multicenter study of cardiac complications. Methods For this retrospective cohort study, we will invite ≥5-year childhood cancer survivors who were treated at the University Children's Hospital Bern, Switzerland with any chemotherapy or cardiac radiation since 1976 and who are ≥18 years of age at the time of the study for a cardiac assessment at the University Hospital Bern. This includes 544 childhood cancer survivors, of whom about half were treated with anthracyclines and/or cardiac radiation and half with any other chemotherapy. The standardized cardiac assessment includes a medical history focusing on signs of cardiovascular disease and its risk factors, a physical examination, anthropometry, vital parameters, the 1-minute sit-to-stand test, and echocardiography including 2-dimensional speckle tracking. Results We will invite 544 eligible childhood cancer survivors (median age at the time of the study, 32.5 years; median length of time since diagnosis, 25.0 years) for a cardiac assessment. Of these survivors, 300 (55%) are at high risk, and 244 (45%) are at standard risk of cardiac dysfunction. Conclusions This study will determine the prevalence of preclinical cardiac dysfunction in Swiss childhood cancer survivors, inform whether speckle tracking echocardiography is more sensitive to cardiac dysfunction than conventional echocardiography, and give a detailed picture of risk factors for cardiac dysfunction. The results will help improve primary treatment and follow-up care of children with cancer. Trial Registration ClinicalTrials.gov NCT03790943; https://clinicaltrials.gov/ct2/show/NCT03790943 International Registered Report Identifier (IRRID) DERR1-10.2196/17724
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Schmid, Julia, Bianca Schmidli, Lisa Hillebrecht, Christina Schindera, Nicolas Von der Weid, Eva Katharina Brack, and Valentin Benzing. "Physical activity counseling within the «KiKli Fit»-project: Development and first implementation." Current Issues in Sport Science (CISS) 9, no. 2 (February 6, 2024): 018. http://dx.doi.org/10.36950/2024.2ciss018.
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Introduction Increasing physical activity (PA) levels in children and adolescents with cancer holds promise for enhancing outcomes both during treatment and into survivorship (Stout et al., 2017). Despite this potential, the promotion of PA within Swiss pediatric oncology units remains largely overlooked. To address this gap, the “KiKli Fit” project has been initiated. This program features personalized training sessions during acute care, accompanied by PA counseling during the transition to the post-acute phase. Importantly, it engages not only the patients but also their families, since they play a crucial role in shaping youth’s PA behavior (Cheung et al., 2021). The PA counseling is designed to enhance motivation, volition, enjoyment, family health-climate, and ultimately, foster an active lifestyle (Schorno et al., 2022). This study aims to outline the theoretical development of the counseling approach and present initial findings from its implementation. Methods We plan a two-arm multicenter crossover-controlled trial to investigate the effects of the whole PA program. The trial will compare the PA program (intervention group in Bern, n = 40) with standard treatment (control group in Basel, n = 40). Participants will be aged 6-18, newly diagnosed with cancer and undergoing neurotoxic treatment for at least six weeks. The PA counseling comprises four sessions involving the child or adolescent and their parents. These sessions cover various topics, including parental concerns about their child performing PA, individual preferences in exercise and sports, and ways to be physically active as a whole family. Motivational interviewing techniques are applied across all sessions. The study will start in early 2024. Outcomes will be measured three times (once at admission, after twelve weeks of intervention and for follow-up after six months). Discussion The “KiKli Fit”-project is a complex program that aims to promote PA in and after acute care by combining personalized training sessions with PA counseling. The scalability of the PA counseling is a key advantage, allowing it to reach a wide demographic, including those who have completed treatment. Fostering PA in young cancer patients seems to particularly important because it can set a foundation for a healthier lifestyle as they transition into adulthood. References Cheung, A. T., Li, W. H. C., Ho, L. L. K., Chan, G. C. F., & Chung, J. O. K. (2021). Parental perspectives on promoting physical activity for their children surviving cancer: A qualitative study. Patient Education and Counseling, 104(7), 1719-1725. https://doi.org/10.1016/j.pec.2020.11.009 Schorno, N., Gut, V., Conzelmann, A., & Schmid, J. (2022). Effectiveness of individual exercise and sport counseling based on motives and goals: A randomized controlled trial. Journal of Sport and Exercise Psychology, 44(2), 103-115. https://doi.org/10.1123/jsep.2021-0018 Stout, N. L., Baima, J., Swisher, A. K., Winters-Stone, K. M., & Welsh, J. (2017). A systematic review of exercise systematic reviews in the cancer literature (2005-2017). PM&R, 9, 347-384. https://doi.org/10.1016/j.pmrj.2017.07.074
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Stuby, Loric, Ludivine Currat, Birgit Gartner, Mathieu Mayoraz, Stephan Harbarth, Laurent Suppan, and Mélanie Suppan. "Impact of Face-to-Face Teaching in Addition to Electronic Learning on Personal Protective Equipment Doffing Proficiency in Student Paramedics: Protocol for a Randomized Controlled Trial." JMIR Research Protocols 10, no. 4 (April 30, 2021): e26927. http://dx.doi.org/10.2196/26927.
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Background The COVID-19 pandemic has brought attention to the importance of correctly using personal protective equipment (PPE). Doffing is a critical phase that increases the risk of contamination of health care workers. Although a gamified electronic learning (e-learning) module has been shown to increase the adequate choice of PPE among prehospital personnel, it failed to enhance knowledge regarding donning and doffing sequences. Adding other training modalities such as face-to-face training to these e-learning tools is therefore necessary to increase prehospital staff proficiency and thus help reduce the risk of contamination. Objective The aim of this study is to assess the impact of the Peyton 4-step approach in addition to a gamified e-learning module for teaching the PPE doffing sequence to first-year paramedic students. Methods Participants will first follow a gamified e-learning module before being randomized into one of two groups. In the control group, participants will be asked to perform a PPE doffing sequence, which will be video-recorded to allow for subsequent assessment. In the experimental group, participants will first undergo face-to-face training performed by third-year students using the Peyton 4-step approach before performing the doffing sequence themselves, which will also be video-recorded. All participants will then be asked to reconstruct the doffing sequence on an online platform. The recorded sequences will be assessed independently by two investigators: a prehospital emergency medicine expert and an infection prevention and control specialist. The assessors will be blinded to group allocation. Four to eight weeks after this first intervention, all participants will be asked to record the doffing sequence once again for a subsequent skill retention assessment and to reconstruct the sequence on the same online platform to assess knowledge retention. Finally, participants belonging to the control group will follow face-to-face training. Results The study protocol has been presented to the regional ethics committee (Req-2020-01340), which issued a declaration of no objection as such projects do not fall within the scope of the Swiss federal law on human research. Study sessions were performed in January and February 2021 in Geneva, and will be performed in April and June 2021 in Bern. Conclusions This study should help to determine whether face-to-face training using the Peyton 4-step approach improves the application and knowledge retention of a complex procedure when combined with an e-learning module. International Registered Report Identifier (IRRID) PRR1-10.2196/26927
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Noetzel, David, and Becky Sheets. "Potato Leafhopper Control in Dry (Kidney) Bean, 1992." Insecticide and Acaricide Tests 18, no. 1 (January 1, 1993): 82. http://dx.doi.org/10.1093/iat/18.1.82.
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Abstract In earlier trials on navy bean, insecticide use against foliar insects appeared to reduce yields. This trial was established at the Staples Irrigation Station using kidney bean as the plant host. The field was planted on 20 May with 4 row plots, each row 0.76 m wide and 7.6 m long, arranged in a randomized complete block design, replicated 4 times. Soil treatments were banded in a 10 cm. band over the row the day of planting. Foliars were applied on 11 and 29 Jul using 2 liter of total material on 0.0023 ha. All plots were regularly irrigated. Data on stand, moisture and yield were collected and final yields adjusted to a standard moisture.
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Weber, Manuel, Anja Maria Raab, Kai-Uwe Schmitt, Gilbert Büsching, Thimo Marcin, Marc Spielmanns, Milo Alan Puhan, and Anja Frei. "Efficacy of a digital lifestyle intervention on health-related QUAlity of life in non-small cell LUng CAncer survivors following inpatient rehabilitation: protocol of the QUALUCA Swiss multicentre randomised controlled trial." BMJ Open 14, no. 3 (March 2024): e081397. http://dx.doi.org/10.1136/bmjopen-2023-081397.
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Introduction Non-small cell lung cancer (NSCLC) survivors suffer from impaired physical and psychological functioning and reduced health-related quality of life (HRQoL) that persist after active treatment ends. Sustaining rehabilitation benefits, promoting a healthy lifestyle and facilitating self-management at home require a multifaceted aftercare programme. We aim to investigate the effect of a 12-week digital lifestyle intervention on HRQoL and lifestyle-related outcomes in NSCLC survivors after completion of inpatient rehabilitation. Methods and analysis QUAlity of life in LUng CAncer Survivors (QUALUCA) is a multicentre randomised controlled trial that follows a hybrid type 1 design. We randomly allocate participants in a 1:1 ratio to the intervention group (digital lifestyle intervention) or the control group (standard care) using block randomisation stratified by tumour stage and study site. Four accredited Swiss inpatient rehabilitation centres recruit participants. Key inclusion criteria are a diagnosis of NSCLC, an estimated life expectancy of ≥6 months and access to a smartphone or tablet. The 12-week intervention comprises physical activity, nutrition and breathing/relaxation, delivered through a mobile application (app). The primary outcome is the change in HRQoL from baseline (1 week after rehabilitation) to follow-up (3 months after baseline), assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Secondary outcomes include body mass index, self-reported physical activity, exercise capacity, risk of low protein intake, appetite, psychological distress, cancer-related fatigue, enablement and self-rated health. Explanatory outcomes in the intervention group include app usability, acceptability, appropriateness, and feasibility of the intervention, experiences and satisfaction with the intervention, and app usage data. We aim to enrol 88 participants. For the main statistical analysis, we will use analysis of covariance, adjusted for baseline measures, stratification variables, age and sex. Ethics and dissemination The Ethics Committees of the Canton of Zurich (lead), the Canton of Bern and Northwest and Central Switzerland approved the study (2023-00245). We will disseminate study results to researchers, health professionals, study participants and relevant organisations, and through publications in international peer-reviewed journals. Trial registration number NCT05819346.
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Schoffski, Patrick, Che-Jui Lee, Tom Van Cann, Jasmien Wellens, Inti Zlobec, Judith V. M. G. Bovée, Christian Britschgi, Raf Sciot, and Agnieszka Wozniak. "Establishment of a tissue microarray (TMA) platform as an efficient tool for soft tissue sarcoma (STS) research available for collaboration." Journal of Global Oncology 5, suppl (October 7, 2019): 38. http://dx.doi.org/10.1200/jgo.2019.5.suppl.38.
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38 Background: STS is a very heterogeneous family of orphan malignancies, characterized by morphological and genetic diversity. Tissue samples from individual STS patients are commonly used for routine diagnostic and research purposes. TMAs from multiple sarcoma tissue blocks have potential advantages over conventional tissue analysis in terms of efficiency and cost-effectiveness. We have established a comprehensive sarcoma TMA research platform. Methods: TMAs were constructed using left-over tissue from STS patients diagnosed at University Hospitals Leuven (B), Leiden University Medical Center (NL) and University Hospital Zürich (CH), and from patients with orphan sarcomas enrolled in EORTC trial 90101 “CREATE”. The clinical cases are well annotated in terms of diagnosis, treatment and follow-up. Each TMA block contains duplicate/triplicate 1.0-1.5 mm tissue cores from representative areas selected by sarcoma pathologists. The construction of TMAs was performed using TMA Grand Master (3DHistech) at University of Bern (CH) and in Leiden (NL). Results: The following subtype-specific TMAs have been created: clear cell sarcoma (CCSA, 54 cases), alveolar soft part sarcoma (ASPS, 59), inflammatory myofibroblastic tumor (IMFT, 33), alveolar rhabdomyo- (24) and leiomyosarcoma (55). For CCSA, ASPS and IMFT we have matching TMAs from clinical routine and patients entered in EORTC 90101. As a tool for broader drug- and target-screening purposes in STS we also produced a multi-sarcoma TMA combining multiple, more common subtypes on one block: angio-, dedifferentiated, pleomorphic and myxoid lipo-, leiomyo-, myxofibro-, rhabdomyo-, synovial and undifferentiated pleomorphic sarcoma, and MPNST, with 7-11 individual cases per tumor type. TMA construction is ongoing in other relevant sarcoma subtypes. Conclusions: We are currently expanding a very useful TMA platform representing the broad heterogeneity of STS, from more common to ultra-rare variants. TMAs are available for rapid, cost-effective morphological, histochemical and molecular characterization and identification of novel drug targets in collaboration with academic and commercial partners.
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Hlubocky, F. J., E. Larson, G. Sachs, and C. K. Daugherty. "A study of informed consent (IC), age, and cognitive function (CF) among advanced cancer patients (acp) in phase I trials." Journal of Clinical Oncology 25, no. 18_suppl (June 20, 2007): 6548. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.6548.
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6548 Background: Ethical concerns exist about acps’ ability to provide adequate informed consent (IC) for phase I trials. While cognitive impairment (CI) among acp is well-recognized due to multiple factors, e.g., previous effects of chemotherapy, age, psychological status, the prevalence of CI among acp in phase I trials has never been described. Methods: Acp CF was assessed using a neuropsychological battery of instruments: Hopkins Verbal Learning (HVLT); Verbal Fluency; Mini-Cognitive Assessment; Trail-making (Parts A& B); Boston Naming (short); WAIS subtests (Comprehension and Digit Span). Acp underwent semi-structured interviews to evaluate elements of IC, and completed the FACT-COG and the Hospital Anxiety and Depression Scale (HADS). Results: To date, a total of 34 acp enrolling in Phase I trials have been studied. Median age: 63y (range: 38–81y); 77% male; 77% Caucasian; 67% > HS education. Regarding IC understanding: Only 20% of responding acp correctly identified the purpose of Phase I trials; all subjects could recall risks of side effects, correctly stated they could refuse trial participation, and stated they could withdraw at anytime; 53% believed the trial was their only option. Older acp (>age 55y) were less likely to correctly describe the research purpose of the trial (29% v. 71% p=0.02). Older acp had measurable deficits in CF: Boston Naming (14±0.9 v.15±0.3, p=0.09); HVLT Total Recall (14±2 v.26±6, p<0.00) and Discrimination Index (7.5±3 v.11±1, p=0.03); Digit Span-Backwards (4±2 v.7±2, p<0.00); Trail-making B (244±64 v.188±51, p=0.04). While there were no differences in perceived CI (95±18 v.101±19, p=0.5) or impact on quality of life (25±7 v. 27±5, p=0.5), both groups had scores well below prior reported means. Older acp tended to report depressive symptoms more than younger acp (8±2 v.6±1, p=0.07). Conclusions: Our data suggest that CF may play a role in acp understanding of IC for clinical trials, especially among the elderly. Further research is needed, given ethical concerns regarding elderly acp in clinical trials of experimental agents who may have CI. No significant financial relationships to disclose.
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Kness, Andrew A., Gordon Johnson, Kathryne L. Everts, Thomas A. Evans, Nicole M. Donofrio, and Emmalea G. Ernest. "Managing Pod Rot of Lima Bean Caused by Phytophthora capsici with Fungicides in the Mid-Atlantic Region." Plant Health Progress 17, no. 2 (January 2016): 130–32. http://dx.doi.org/10.1094/php-br-16-0015.
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The baby lima bean (Phaseolus lunatus) is one of the most economically important crops for Delaware. Pod rot of lima bean caused by Phytophthora capsici is a relatively new disease that threatens production and profitability of lima beans grown in Delaware and the mid-Atlantic region. Insensitivity to the fungicide mefenoxam has made managing the disease challenging in recent years. In 2014, 12 fungicides in two trials were tested for their efficacy against P. capsici in lima bean. Results indicated that all fungicide treatments significantly reduced disease incidence compared to the control, with oxathiapiprolin achieving the best control in Trial 1 and fluazinam and mefenoxam achieving the best control in Trial 2. Fungicide treated plots also yielded significantly greater than controls in Trial 2. These results indicate that there are additional fungicides on the market with efficacy towards managing pod rot of lima bean and warrant further investigation for possible new labels. Accepted for publication 16 May 2016. Published 9 June 2016.
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Kundu, Manjari, Yoshimi Endo Greer, Jennifer L. Dine, and Stanley Lipkowitz. "Targeting TRAIL Death Receptors in Triple-Negative Breast Cancers: Challenges and Strategies for Cancer Therapy." Cells 11, no. 23 (November 22, 2022): 3717. http://dx.doi.org/10.3390/cells11233717.
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The tumor necrosis factor (TNF) superfamily member TNF-related apoptosis-inducing ligand (TRAIL) induces apoptosis in cancer cells via death receptor (DR) activation with little toxicity to normal cells or tissues. The selectivity for activating apoptosis in cancer cells confers an ideal therapeutic characteristic to TRAIL, which has led to the development and clinical testing of many DR agonists. However, TRAIL/DR targeting therapies have been widely ineffective in clinical trials of various malignancies for reasons that remain poorly understood. Triple negative breast cancer (TNBC) has the worst prognosis among breast cancers. Targeting the TRAIL DR pathway has shown notable efficacy in a subset of TNBC in preclinical models but again has not shown appreciable activity in clinical trials. In this review, we will discuss the signaling components and mechanisms governing TRAIL pathway activation and clinical trial findings discussed with a focus on TNBC. Challenges and potential solutions for using DR agonists in the clinic are also discussed, including consideration of the pharmacokinetic and pharmacodynamic properties of DR agonists, patient selection by predictive biomarkers, and potential combination therapies. Moreover, recent findings on the impact of TRAIL treatment on the immune response, as well as novel strategies to address those challenges, are discussed.
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Cullen, Stephen M., Mairi-Ann Cullen, and Geoff Lindsay. "The CANparent trial-the delivery of universal parenting education in England." British Educational Research Journal 43, no. 4 (May 15, 2017): 759–80. http://dx.doi.org/10.1002/berj.3282.
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Rogan, Slavko, Eefje Luijckx, Jan Taeymans, Karin Haas, and Heiner Baur. "Physical Activity, Nutritional Habits, and Sleep Behavior Among Health Profession Students and Employees of a Swiss University During and After COVID-19 Confinement: Protocol for a Longitudinal Observational Study." JMIR Research Protocols 9, no. 12 (December 22, 2020): e25051. http://dx.doi.org/10.2196/25051.
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Background SARS-CoV-2, a novel coronavirus strain, has resulted in the COVID-19 pandemic since early 2020. To contain the transmission of this virus, the Swiss Federal Council ordered a nationwide lockdown of all nonessential businesses. Accordingly, students and employees of institutions for higher education were informed to continue their academic programs through home-office settings and online lectures. Objective This longitudinal survey aims to evaluate various lifestyle habits such as physical activity, nutritional habits, and sleep behavior among students and employees of a Swiss University of Applied Sciences during a 2-month period of confinement and social distancing due to the COVID-19 pandemic and 1 year thereafter. Methods This paper describes a protocol for a retrospective and prospective observational cohort study. Students and employees of Bern University of Applied Sciences, Department of Health Professions, were invited to anonymously complete a web-based survey during the COVID-19 confinement period. This will be followed by a second survey, scheduled 1 year after the lockdown. Information on various lifestyle aspects, including physical activity, nutritional habits, and sleep behavior, will be collected using adaptations of existing validated questionnaires. Results This longitudinal study started during the government-ordered confinement period in Switzerland in mid-April 2020 and will end in mid-2021. Conclusions The findings of this survey will provide information about the impact of confinement during the COVID-19 crisis on the physical activity, nutritional habits, and sleep behavior of students and employees of a Swiss institute. Trial Registration ClinicalTrials.gov NCT04502108; https://www.clinicaltrials.gov/ct2/show/NCT04502108 International Registered Report Identifier (IRRID) DERR1-10.2196/25051
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Park, Hyungkwan. "The Principle of the Judge immobility and Public Trial Base Principle." Korean Association of Criminal Procedure Law 15, no. 4 (December 31, 2023): 97–129. http://dx.doi.org/10.34222/kdps.2023.15.4.97.
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Under the Korean Supreme Court Personnel Order, a regular transfer of judges to different jurisdictions is effected at preset terms. This practice is highly unusual and although the practice was undoubtedly a measure in securing a more sound legal system, troubling side effects have occurred. Two prominent examples include the undermining of the right of a citizen's right to a speedy trial and a weakening of the public trial principle. Changing judges during a trial is akin to changing an umpire during a sporting event.
The practice is not only inefficient but places an unfair burden on the parties to reestablish their case anew before a new judge. This is an example of why most countries ensure the principle of judge immobility wherein judges are not moved to new jurisdictions nor promoted without consent. The public trial base principle maintains that a judge's decision in rendering a guilty or not guilty verdict should be formed mainly in the open courts. This principle includes the principle of direct evidence investigation, concentration of trial procedure, and public trials among others. In the past, Korea criminal procedure had depended largely on the principle of protocol trials, wherein a decision was largely based on the investigating agent's protocols. In an effort to correct the possible biased nature of the practice, the public trial base principle has hence been increasingly emphasized.
When there is a change in the presiding judge, it is extremely difficult to ascertain the reasoning formed through the former trial procedure in rendering a guilty or not guilty decision. Even if the evidence is reinvestigated according to the renewal procedure of the trial, there are limits to what can clearly be reestablished. As a result, frequent changes in the trial bench are tantamount to practically undermining the public trial base principle.
To ensure a citizen's right to a fair and speedy trial and successfully establish the public trial base principle, the principle of judge immobility must be guaranteed. This should be effected not merely as a judicial personnel policy but as a principle in securing the constitutional right of the victim as well as the defendant and in keeping with due process. There are two options to introduce the principle of judge immobility: a comprehensive approach or a gradual introduction. Should the latter be adopted, it should first be introduced at the district court level. Further, in facilitating the preliminary trail procedure and the public trial base principle, the introduction of a vice-judge appointing system would be highly beneficial.
There has been an increasing delay in the trial procedure of major trials. It is high time to guarantee the principle of immobility of judges to ensure the right of citizens to receive fair and speedy trials and to further solidify the public trial base principle in our legal systems.
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Allan, C., A. Chapman, C. Parker, A. Boltong, and J. Millar. "Missing Evidence: Exploring Unpublished Trials in Victoria, Australia." Journal of Global Oncology 4, Supplement 2 (October 1, 2018): 96s. http://dx.doi.org/10.1200/jgo.18.28700.
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Background: Clinical trial registries were established to improve the transparency and completeness of clinical trial reporting and a number of policies have been introduced to encourage or mandate their use. While prospective trial registration has been endorsed in Australia, there is currently no legal requirement for researchers to register or communicate findings from clinical trials. There has also been, to the best of our knowledge, no analysis previously undertaken on publication rates for clinical trials performed in Australia. Aim: We aimed to determine the proportion of clinical trials that remain 'unpublished' in Victoria, Australia´s second most populous state, between 2009 and 2013. Methods: We used data reported to Cancer Council Victoria's Cancer Trials Management Scheme (CTMS) between 2009 and 2013, to identify trials that had recruited a new patient or recorded any follow-up patient activity in the specified time period. Using this data, we conducted a systematic search of ClinicalTrials.gov , the Australia and New Zealand Clinical Trials Registry (ANZCTR), PubMed and Google for records of the trial. Trial registration numbers, acronyms and scientific titles were used as primary search terms. Results were characterized by type of publication (i.e., whether it was an accredited scientific paper or other) and source location. Results: Of the trials reported to the CTMS between 2009 and 2013, 777 trials were included in this investigation; the majority (58.8%) were randomized controlled trials (RCTs). Compared with previously published findings, communication of trial results in this study was high; 70% of trials published results in an accredited scientific journal and a further 10% in alternate form, such as a conference abstract or media release. Publication rates were higher for trials with a commercial sponsor (85%) compared with trials sponsored by a cooperative group (77%). Nearly 8% of trials in this study had not been registered on an international clinical trials register. Only 39% of unregistered trials had published results. Of the registered trials, those registered on ClinicalTrials.gov were more likely to be published (86%) compared with trials listed on ANZCTR (68%). Between 2009 and 2013 , 8% of trials registered on ClinicalTrials.gov , in our data set, were terminated; 70% of these trials published results. Conclusion: Although the rate at which clinical trial findings were published in Victoria was higher in this investigation compared with equivalent overseas data, trials registered on ClinicalTrials.gov were more likely to publish results than unregistered trials or trials registered on ANZCTR. This suggests a potential need for trial registration and publication guidelines in Australia, similar to that of the United States where the requirements and procedures for submitting registration and summary result information for clinical trials on ClinicalTrials.gov have been compulsory for the last decade.
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Ellaway-Barnard, Christopher, Hannah Killick, Guy Peryer, Jane L. Cross, and Toby O. Smith. "The association between registration status and reported outcomes in physiotherapy randomised controlled trials." International Journal of Therapy and Rehabilitation 27, no. 3 (March 2, 2020): 1–15. http://dx.doi.org/10.12968/ijtr.2019.0023.
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Background/Aims Clinical trial registration has been proposed as a method of mitigating selective reporting in scientific research. It remains unknown whether trial registration is associated with reported outcomes in physiotherapy trials. This study aimed to analyse the association between registration status and outcome (the rejection or acceptance of a primary null hypothesis) for physiotherapy randomised controlled trials. Methods All randomised controlled trials reporting a physiotherapy intervention in publications listed in PubMed between 1 January 2017 and 30 June 2017 were included. Trial registration was determined based on the reporting of a registration number in the primary article or by identifying trials through trial registries. Results Of the 291 trials analysed, 176 (60.5%) were registered; 115 (39.5%) were not. There was no significant association between trial registration and outcome on multivariate analyses (Odds Ratio 1.65; 95% Confidence Interval (0.92–2.96); P=0.09). Only 22% of trials were prospectively registered. Conclusions Registration status and trial outcome are not associated in randomised controlled trials of physiotherapy interventions. The rate of physiotherapy trial registration remains low.
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Tion, M. A., and P. C. Njoku. "Assessing calcium availability from limestone sources through bone and blood status of chickens." Nigerian Journal of Animal Production 36, no. 1 (January 1, 2021): 85–95. http://dx.doi.org/10.51791/njap.v36i1.1396.
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Calcium (Cu) availability from limestone (procured from different cement factories) was assessed through bone and blood status of chickens using the completely randomized design. Five hundred and twenty five (525) straight run broiler chicks that were 28 days Of age (trial l), four hundred and twenty (420) broiler finishers that were 56 days of age (trial 2), and 210 layers that had been laying for six months (trial 3) were used in the study. Six limestone dietary treatments and a control accounted for the seven diets that were assessed Twelve birds per treatment and 4 per replicate that had their weights close to the mean of the pen were selected in the broiler trials (trials I and 2) and three birds per pen and nine per diet were selected in the layer trial (trial 3) for bone and blood samples analysis. Bone samples were analyzed for bone weight, bone length, ash weight, percentage ash, Ca and phosphorus contents of ash and blood samples were analyzed for plasma Ca and alkaline phosphates activity. Results showed similar influence of sources on bone weight, bone length, ash weight and percentage ash. Ca and P contents of ash were significantly (P<0.05) affected by limestone sources but generally. Limestone sources produced mean values that were equal to or than the control diet in the starter phase (trail 1). In the finisher phase (trial 2), only Ca content of ashy varied significantly where Jakura source produced the least mean value. The layer trial (trial 3) also produced mean values that were significant (P <0.05) for Ca content of ash with the Sokoto source producing the least mean value. Plasma Ca and alkaline phosphates enzyme activity attained published values for chickens. It was concluded based on the information from this study that the (h from tested limestone sources was generally available for chicken production.
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Guo, Chenguang, Congsen Li, Guoping Shen, and HaiYu Zhou. "Characteristics and trends of globally registered malignant pleural mesothelioma clinical trials in the past 27 years." Journal of Clinical Oncology 41, no. 16_suppl (June 1, 2023): e20544-e20544. http://dx.doi.org/10.1200/jco.2023.41.16_suppl.e20544.
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e20544 Background: Malignant pleural mesothelioma (MPM), arising from the serosal lining of the thoracic cavity, is a rare malignancy with limited treatment options and very poor prognosis. Recent progress in immunotherapy and innovative devices have advanced treatment fields of MPM. To help investigators understand the landscape of MPM clinical research, characteristic and trends of globally registered trials in the past decades were analyzed in our study. Methods: This is a cross-sectional analysis of MPM trials registered on ClinicalTrials.gov between January 1996 and December 2022. Characteristics pertaining to trail phase, enrollment number, study design, type, funding source, age of population, trial purpose, and participating country were extracted, and chronological shifts were analyzed. Clinical trial variables were enumerated using descriptive statistics and categorical data were presented as frequencies and percentages. Chi-square trend analysis (Cochran–Armitage trend test) was used to evaluate the trend of MPM trials. Results: 267 registered MPM trials were analyzed involving 40 participating countries among which the United States, the United Kingdom, and Italy were top 3. 8.2% trials were phase 3 and 18.7% were randomized. 74 trials had publications by the December 2022. The trial purposes concerning surgery, radiotherapy, chemotherapy, target therapy, immunotherapy, photodynamic therapy, cryotherapy, tumor treating fields （TTF）and non-anticancer research accounted for 2.6%, 5.2%, 20.2%, 25.5%, 31.1%, 1.1%, 0.7%, 0.7% and 12.7% respectively. In the past 27 years, the numbers of chemotherapy and targeted therapy trials declined while immunotherapy trails steadily escalated (all above ptrend < 0.05). There are no significant changes for the trends of each trial phase. 205 drug therapy trials involved 26 cytotoxic drugs, 44 targeted drugs and 11 immune checkpoint inhibitors and 34 other drugs. Pemetrexed-cisplatin with TTF and ipilimumab-nivolumab have changed the frontline treatment space while improvement for regulatory approvals has been far slower in salvage treatment, with the median overall survival all less than 11 months in phase 3 trials. There are no definitive trials that justify the use of predictive biomarkers for systemic therapy in MPM. Conclusions: Immunotherapy and TTF have reshaped the standard of care landscape over the past 27 years. With the enhanced understanding of molecular characteristics and mechanism of MPM, it is anticipated that ongoing immunotherapy combined with target therapy, chemotherapy or other novel treatment can improve the frontline and post-line therapeutic effect.
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Bruckner, Till, Daniel Sanchez, Tarik Suljic, Okan Basegmez, Tungamirai Ishe Bvute, Carolina Cruz, Dominic Grzegorzek, et al. "Regulatory gaps and research waste in clinical trials involving women with metastatic breast cancer in Germany." F1000Research 13 (May 1, 2024): 431. http://dx.doi.org/10.12688/f1000research.148958.1.
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Background Non-publication, incomplete publication and excessively slow publication of clinical trial outcomes contribute to research waste and can harm patients. While research waste in German academic trials is well documented, research waste in Germany related to a specific disease area across non-commercial and commercial sponsors has not previously been assessed. Methods In this cohort study, we used public records from three clinical trial registries to identify 70 completed or terminated clinical trials involving women with metastatic breast cancer with trial sites in Germany. We then searched registries and the literature for trial outcomes and contacted sponsors about unreported studies. Results We found that 66/70 trials (94.3%) had made their results public. Only 13/70 (18.6%) trials had reported results within one year of completion as recommended by the World Health Organisation (WHO). The outcomes of 4/70 trials (5.7%) had not been made public at all, but only one of those trials had recruited a significant number of patients. Conclusions Discussions about research waste in clinical trials commonly focus on weakly designed or unreported trials. We believe that late reporting of results is another important form of research waste. In addition, a discussion regarding the appropriate ethical and legal rules for reporting the results of terminated trials might add value. German legislation now requires sponsors to upload the results of some clinical trials onto a trial registry within one year of trial completion, but these laws only cover around half of all trials. Our findings highlight the potential benefits of extending the scope of national legislation to cover all interventional clinical trials involving German patients.
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Lloyd, Kirsten L., Donald D. Davis, Richard P. Marini, and Dennis R. Decoteau. "Effects of Nighttime Ozone Treatment at Ambient Concentrations on Sensitive and Resistant Snap Bean Genotypes." Journal of the American Society for Horticultural Science 143, no. 1 (January 2018): 23–33. http://dx.doi.org/10.21273/jashs04253-17.
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The effect of nighttime ozone (O3) exposure, alone and in combination with daytime O3 treatment, was tested on yield of an O3-resistant (R123) and an O3-sensitive (S156) snap bean (Phaseolus vulgaris L.) genotype. Three trials, with exposure durations ranging in length from 14 to 21 days, were conducted in continuous stirred tank reactors located within a greenhouse. The effects of day-only (0800–1900 hr = 11 hours·day−1) and day + night (0800–1900 hr + 2000–0700 hr = 22 hours·day−1) exposure timings were compared. The Fall 2014 trial also tested the effect of nighttime-only (2000–0700 hr = 11 hours·day−1) O3 exposure. Nighttime O3 exposure alone, at 62 ppb, did not cause foliar injury and had no effect on the yield of either genotype. In combination with daytime O3 exposure, nighttime O3 concentrations up to 78 ppb did not impact yields or show a consistent effect on nocturnal stomatal conductance (gsn). When data were pooled across the day and day + night exposures times, mean daytime O3 levels ≥62 ppb caused foliar injury and significant yield decreases in all three trials. Under control conditions, R123 and S156 produced similar pod masses in two of the three trials. In all three trials, R123 produced significantly greater yields by mass than S156 with elevated O3. Nighttime conductance measurements suggested that S156 and R123 have inherently different gsn rates and that cumulative O3 exposure can increase gsn in both genotypes.
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Elkin, Magdalyn E., and Xingquan Zhu. "Understanding and predicting COVID-19 clinical trial completion vs. cessation." PLOS ONE 16, no. 7 (July 12, 2021): e0253789. http://dx.doi.org/10.1371/journal.pone.0253789.
Full textAbstract:
As of March 30 2021, over 5,193 COVID-19 clinical trials have been registered through Clinicaltrial.gov. Among them, 191 trials were terminated, suspended, or withdrawn (indicating the cessation of the study). On the other hand, 909 trials have been completed (indicating the completion of the study). In this study, we propose to study underlying factors of COVID-19 trial completion vs. cessation, and design predictive models to accurately predict whether a COVID-19 trial may complete or cease in the future. We collect 4,441 COVID-19 trials from ClinicalTrial.gov to build a testbed, and design four types of features to characterize clinical trial administration, eligibility, study information, criteria, drug types, study keywords, as well as embedding features commonly used in the state-of-the-art machine learning. Our study shows that drug features and study keywords are most informative features, but all four types of features are essential for accurate trial prediction. By using predictive models, our approach achieves more than 0.87 AUC (Area Under the Curve) score and 0.81 balanced accuracy to correctly predict COVID-19 clinical trial completion vs. cessation. Our research shows that computational methods can deliver effective features to understand difference between completed vs. ceased COVID-19 trials. In addition, such models can also predict COVID-19 trial status with satisfactory accuracy, and help stakeholders better plan trials and minimize costs.
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Geller, N. L. "Planned interim analysis and its role in cancer clinical trials." Journal of Clinical Oncology 5, no. 9 (September 1987): 1485–90. http://dx.doi.org/10.1200/jco.1987.5.9.1485.
Full textAbstract:
Although interim analyses in cancer clinical trials are commonplace, clinical trials are usually designed with the implicit assumption that data analysis will occur only after the trial is completed. The design of randomized trials with planned interim analyses, "group sequential trials," is described and examples are given. A method to redesign trials in which unplanned interim analyses have been undertaken is described. Planned interim analysis should be considered whenever a cancer clinical trial is designed.
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Dalrymple, H. W. "The general data protection regulation, the clinical trial regulation and some complex interplay in paediatric clinical trials." European Journal of Pediatrics 180, no. 5 (January 18, 2021): 1371–79. http://dx.doi.org/10.1007/s00431-021-03933-3.
Full textAbstract:
AbstractAlthough a number of authors have commented upon the impact of the GDPR on clinical trial conduct, few have examined the specific setting of paediatric trials. Whilst the general principles are the same as those for adults, some additional considerations arise. The ages of consent relating to data privacy and clinical trial participation are different in a number of countries, but the distinction is often not recognised in non-drug trials. Accidental pregnancies in clinical trials always raise complexities, but these are amplified when the trial subject is a minor, and the processes described in clinical trial protocols rarely take account of GDPR requirements. This paper describes approaches which can be taken to ensure the rights of children are respected.Conclusion: The conduct of paediatric clinical trials within GDPR requirements is quite possible provided authors think carefully when drafting protocols. What is Known:•GDPR is applicable to clinical trials, including paediatric trials.•A number of challenges at the interface between the GDPR and CTR have been described. What is New:•The application of the GDPR to certain specific situations in paediatric trials does not appear to have been explored.•Three such situations are described and solutions offered.
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Moorcraft, Sing Yu, Cheryl Marriott, Clare Peckitt, David Cunningham, Ian Chau, Naureen Starling, David Watkins, Jervoise Andreyev, and Sheela Rao. "A prospective patient (pt) survey on clinical trials." Journal of Clinical Oncology 33, no. 3_suppl (January 20, 2015): 707. http://dx.doi.org/10.1200/jco.2015.33.3_suppl.707.
Full textAbstract:
707 Background: Recruitment to clinical trials can be challenging. We conducted a patient survey to improve our understanding of pts’ views and experiences of clinical trials and what aspects could be improved. Methods: Pts who had been approached about participation in any clinical trial in the Gastrointestinal (GI) and Lymphoma Unit at the Royal Marsden were prospectively invited to complete a questionnaire about their views and experiences of cancer research. Results: Between August 2013 and July 2014, 276 pts (90% GI, 10% lymphoma) received 298 clinical trial pt information sheets (PIS) and were asked to complete a questionnaire. 263 respondents (Res) consented to a trial and 249 of these (95%) completed the questionnaire (65 for clinical trials of an investigational medicinal product (CTIMP), 156 for non-CTIMPs and 28 for molecular pre-screening trials). 25 Res declined a trial and 10 of these completed the questionnaire. Of the 249 Res who consented to a trial, 96% were glad to be approached about clinical trials. 90% of Res felt the PIS was easy to understand and rated the verbal explanation of the trial as excellent/good. 10 Res who declined a trial felt the verbal explanation was excellent/good and that the PIS was easy to understand. The mean total PIS length (including sub-studies) was 17 pages (range 3-50 pages). 9% of Res who consented to a trial felt the PIS was too long. Regarding CTIMP trials, 48-50% of Res would have liked more information on trial drugs and any additional research procedures, 28-30% were neutral and 20-24% did not want more information. 75% of Res would consider participating in studies requiring a research biopsy and 78% would donate their tissue for genetic research. 79% of pre-screening trial Res, 66% of non-CTIMP trial Res and 54% of CTIMP trial Res would have been willing to consent to the trial on the day they received the PIS. 75% of Res (including 89% of CTIMP Res) believed pts should be told trial results, even if results are not available for many years. Conclusions: The majority of pts are willing to be approached regarding clinical trials. A high proportion of pts would consider studies involving research biopsies. New strategies for tailoring additional trial information according to the patient and informing pts of trial results should be explored.