Trends in UK cancer trials: results from the UK Coordinating Committee for Cancer Research National Register of Cancer Trials

We aimed to study trends in the design and conduct of randomised controlled trials (RCTs) in cancer in the UK, using the UK Coordinating Committee for Cancer Research (UKCCCR) National Register of Cancer Trials (NRCT). We conducted a descriptive survey of 520 UK RCTs in cancer that were registered on the UKCCCR NRCT. All trials had been initiated between 1971 and 2000. Trials on the NRCT have been conducted in a wide variety of cancer types, but with a third in breast (22%) or lung cancer (11%). They have largely been funded by the UK public and charity sectors. Overall, there has been a sustained rise in the total numbers of patients entering UK cancer trials over time with a trend towards larger, multicentre trials, greater recruitment targets and a marked reduction in the average time taken to complete trials. Trends in the design and conduct of noncommercial cancer RCTs from 1971 to 2000 are encouraging. It will be interesting to see how they develop in light of the implementation of recent national initiatives regarding cancer clinical trials in the UK

Patient safety culture among European cancer nurses - an exploratory, cross-sectional survey comparing data from Estonia, Germany, Netherlands and United Kingdom

Aim To explore the differences in perceived patient safety culture in cancer nurses working in Estonia, Germany, the Netherlands and the United Kingdom. Design An exploratory cross‐sectional survey. Methods In 2018, 393 cancer nurses completed the 12 dimensions of the Hospital Survey on Patient Safety Culture. Results The mean score for the overall patient safety grade was 61.3. The highest rated dimension was ‘teamwork within units' while ‘staffing' was the lowest in all four countries. Nurses in the Netherlands and in the United Kingdom, scored higher on ‘communication openness', the ‘frequency of events reported' and ‘nonpunitive response to errors', than nurses from Estonia or Germany. We found statistically significant differences between the countries for the association between five of the 12 dimensions with the overall patient safety grade: overall perception of patient safety, communication openness, staffing, handoffs and transitions and nonpunitive response to errors. Conclusion Patient safety culture, as reported by cancer nurses, varies between European countries and contextual factors, such as recognition of the nursing role and education have an impact on it. Cancer nurses' role in promoting patient safety is a key concern and requires better recognition on a European and global level

Quality of life in advanced cancer patients: the impact of sociodemographic and medical characteristics

Population-based surveys have shown that health-related quality of life (HRQL) is influenced by patients' characteristics such as age, gender, living situation and diagnoses. The present study explores the impact of such factors on the HRQL of severely ill cancer patients. The study sample included 395 cancer patients who participated in a cluster randomised trial of palliative care. Median survival was 13 weeks. HRQL assessments (using the EORTC QLQ-C30 questionnaire) were compared among subgroups of relevant patients' characteristics (ANOVA), and the significance of individual covariates was explored by multivariate linear regression. Most EORTC QLQ-C30 scores showed minor differences between genders. Higher age was associated with less sleeping disturbance, less pain and better emotional functioning. No positive impact of living with a partner was found. Performance status and/or time from assessment to death were significantly associated with most functioning and symptom scores. We concluded that although the overall impact of sociodemographic characteristics may seem less important to HRQL scores among advanced cancer patients than in general populations, age and gender should be allowed for. Performance status and closeness to death also need to be reported.   http://www.bjcancer.com © 2001 Cancer Research Campaig

Developing an Initial Program Theory to Explain How Patient-Reported Outcomes Are Used in Health Care Settings: Methodological Process and Lessons Learned

A central aspect of any theory-driven realist investigation (synthesis or evaluation) is to develop an initial program theory (IPT). An IPT can be used to frame and understand how, for whom, why, and under what contexts complex interventions work or not. Despite well-established evidence that IPTs are a central aspect to any realist investigation, there is wide variation and a lack of methodological discussion on how to develop an IPT. In this article, we present the approach that we used to develop an IPT of how patient-reported outcomes (PROs) are used in health care settings. Specifically, we completed a systematic review to extract tacit theories reported in the literature. The benefit of this approach was that it provided a rigorous review of the literature in the development of IPTs. The challenges included (1) rediscovering what is already well established in the theoretical literature, (2) generating an overabundance of partial candidate theories, and (3) extensive use of time and resources for what was the first stage to our larger funded research study. Our recommendations to other scholars considering this approach are to ensure that they (1) live within their means and (2) narrow the scope of the research question and/or develop a conceptual framework using middle-range theories. These methodological insights are highly relevant to researchers embarking on a realist investigation, tasked with developing an IPT

Combinatorial realizations of crystals via torus actions on quiver varieties

Consider Kashiwara's crystal associated to a highest weight representation of a symmetric Kac-Moody algebra. There is a geometric realization of this object using Nakajima's quiver varieties, but in many particular cases it can also be realized by elementary combinatorial methods. Here we propose a framework for extracting combinatorial realizations from the geometric picture: We construct certain torus actions on the quiver varieties and use Morse theory to index the irreducible components by connected components of the subvariety of torus fixed points. We then discuss the case of affine sl(n). There the fixed point components are just points, and are naturally indexed by multi-partitions. There is some choice in our construction, leading to a family of combinatorial models for each highest weight crystal. Applying this construction to the crystal of the fundamental representation recovers a family of combinatorial realizations recently constructed by Fayers. This gives a more conceptual proof of Fayers' result as well as a generalization to higher level. We also discuss a relationship with Nakajima's monomial crystal.Comment: 23 pages, v2: added Section 8 on monomial crystals and some references; v3: many small correction

Quality of life and symptom assessment in randomized clinical trials of bladder cancer: A systematic review

OBJECTIVES: Patient-reported outcomes (PRO) help patients, caretakers, clinicians, and policy makers make informed decisions regarding treatment effectiveness. Our objective was to assess the quality of PRO reporting and methodological strengths and weaknesses in randomized controlled trials (RCT) in bladder cancer.; METHODS: A systematic literature search of bladder cancer RCT published between January 2004 and March 2014 was performed. Relevant studies were evaluated using a predetermined extraction form that included trial demographics, clinical and PRO characteristics, and standards of PRO reporting based on recommendations of the International Society for Quality of Life Research.; RESULTS: In total, 9 RCTs enrolling 1,237 patients were evaluated. All studies were in patients with nonmetastatic disease. In 5 RCTs, a PRO was the primary end point. Most RCTs did not report the mode of administration of the PRO instrument or the methods of collecting data. No RCT addressed the statistical approaches for missing data.; CONCLUSIONS: We found that few RCTs in bladder cancer report PRO as an outcome. Efforts to expand PRO reporting to more RCTs and improve the quality of PRO reporting according to recognized standards are necessary for facilitating clinical decision making. Copyright 2015 Elsevier Inc. All rights reserved