Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 study

BACKGROUND: The absence of trial data comparing robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy is a crucial knowledge gap in uro-oncology. We aimed to compare these two approaches in terms of functional and oncological outcomes and report the early postoperative outcomes at 12 weeks. METHOD: In this randomised controlled phase 3 study, men who had newly diagnosed clinically localised prostate cancer and who had chosen surgery as their treatment approach, were able to read and speak English, had no previous history of head injury, dementia, or psychiatric illness or no other concurrent cancer, had an estimated life expectancy of 10 years or more, and were aged between 35 years and 70 years were eligible and recruited from the Royal Brisbane and Women's Hospital (Brisbane, QLD). Participants were randomly assigned (1:1) to receive either robot-assisted laparoscopic prostatectomy or radical retropubic prostatectomy. Randomisation was computer generated and occurred in blocks of ten. This was an open trial; however, study investigators involved in data analysis were masked to each patient's condition. Further, a masked central pathologist reviewed the biopsy and radical prostatectomy specimens. Primary outcomes were urinary function (urinary domain of EPIC) and sexual function (sexual domain of EPIC and IIEF) at 6 weeks, 12 weeks, and 24 months and oncological outcome (positive surgical margin status and biochemical and imaging evidence of progression at 24 months). The trial was powered to assess health-related and domain-specific quality of life outcomes over 24 months. We report here the early outcomes at 6 weeks and 12 weeks. The per-protocol populations were included in the primary and safety analyses. This trial was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), number ACTRN12611000661976. FINDINGS: Between Aug 23, 2010, and Nov 25, 2014, 326 men were enrolled, of whom 163 were randomly assigned to radical retropubic prostatectomy and 163 to robot-assisted laparoscopic prostatectomy. 18 withdrew (12 assigned to radical retropubic prostatectomy and six assigned to robot-assisted laparoscopic prostatectomy); thus, 151 in the radical retropubic prostatectomy group proceeded to surgery and 157 in the robot-assisted laparoscopic prostatectomy group. 121 assigned to radical retropubic prostatectomy completed the 12 week questionnaire versus 131 assigned to robot-assisted laparoscopic prostatectomy. Urinary function scores did not differ significantly between the radical retropubic prostatectomy group and robot-assisted laparoscopic prostatectomy group at 6 weeks post-surgery (74·50 vs 71·10; p=0·09) or 12 weeks post-surgery (83·80 vs 82·50; p=0·48). Sexual function scores did not differ significantly between the radical retropubic prostatectomy group and robot-assisted laparoscopic prostatectomy group at 6 weeks post-surgery (30·70 vs 32·70; p=0·45) or 12 weeks post-surgery (35·00 vs 38·90; p=0·18). Equivalence testing on the difference between the proportion of positive surgical margins between the two groups (15 [10%] in the radical retropubic prostatectomy group vs 23 [15%] in the robot-assisted laparoscopic prostatectomy group) showed that equality between the two techniques could not be established based on a 90% CI with a Δ of 10%. However, a superiority test showed that the two proportions were not significantly different (p=0·21). 14 patients (9%) in the radical retropubic prostatectomy group versus six (4%) in the robot-assisted laparoscopic prostatectomy group had postoperative complications (p=0·052). 12 (8%) men receiving radical retropubic prostatectomy and three (2%) men receiving robot-assisted laparoscopic prostatectomy experienced intraoperative adverse events. INTERPRETATION: These two techniques yield similar functional outcomes at 12 weeks. Longer term follow-up is needed. In the interim, we encourage patients to choose an experienced surgeon they trust and with whom they have rapport, rather than a specific surgical approach. FUNDING: Cancer Council Queensland.

Adopting an active learning approach to teaching in a research-intensive higher education context transformed staff teaching attitudes and behaviours

The conventional lecture has significant limitations in the higher education context, often leading to a passive learning experience for students. This paper reports a process of transforming teaching and learning with active learning strategies in a research-intensive educational context across a faculty of 45 academic staff and more than 1000 students. A phased approach was used, involving nine staff in a pilot phase during which a common vision and principles were developed. In short, our approach was to mandate a move away from didactic lectures to classes that involved students interacting with content, with each other and with instructors in order to attain domain-specific learning outcomes and generic skills. After refinement, an implementation phase commenced within all first-year subjects, involving 12 staff including three from the pilot group. The staff use of active learning methods in classes increased by sixfold and sevenfold in the pilot and implementation phases, respectively. An analysis of implementation phase exam questions indicated that staff increased their use of questions addressing higher order cognitive skills by 51%. Results of a staff survey indicated that this change in practice was caused by the involvement of staff in the active learning approach. Fifty-six percent of staff respondents indicated that they had maintained constructive alignment as they introduced active learning. After the pilot, only three out of nine staff agreed that they understood what makes for an effective active learning exercise. This rose to seven out of nine staff at the completion of the implementation phase. The development of a common approach with explicit vision and principles and the evaluation and refinement of active learning were effective elements of our transformational change management strategy. Future efforts will focus on ensuring that all staff have the time, skills and pedagogical understanding required to embed constructively aligned active learning within the approach.

Role of knowledge and ability in student nurses` clinical decision-making

Little is known about the acquisition of decision-making skills in nursing students as a function of experience and academic ability. Knowing how experience and academic skills interact may help inform clinical education programs and formulate ways of assessing students' progress. The aims of the present study were to develop a problem-solving task capable of measuring clinical decision-making skills in novice nurses at different levels of domain-specific knowledge; and to establish the relative impact on decision-making of domain-specific knowledge and general ability as determinants of the acquisition of decision-making skills. Three types of clinical problems of increasing complexity were developed. Sixty second-year and third-year student nurses with high and low academic scores were studied in terms of their ability to generate hypotheses for a hypothetical case, recognize disconfirming information and the need to access additional information, and diagnostic accuracy. The results showed that general academic ability and knowledge function partly independently in the acquisition of expertise in nursing. Academic ability affects decision-making in low complexity tasks, but as case complexity increases, domain-specific knowledge and experience determines decision-making skills. There are important differences in the way novices with different levels of knowledge and ability make clinical decisions and these can be studied by systematically increasing the complexity of the decision task. These results have implications for the way in which clinical education is structured and evaluated.

Predicting consumer innovative behavior using alternative theories and likelihood measures: a longitudinal study

This paper reports on a longitudinal study of consumers, where two dominant theories that purport to predict innovative behavior are applied and compared directly, using a methodology suggested as ideal by past researchers. Predictions made prior to launch were then evaluated against multiple measures of purchase likelihood, and against actual adoption behavior up to 12 months after launch. The results of this study suggest that perceptions of the innovations characteristics (PIC) predicted the selfreported likelihood of adoption better than the Domain Specific Innovativeness (DSI) scale, a personality-based measure. Prediction of actual adoption was largely inaccurate and both theories massively over predicted adoption levels, however the DSI scale was slightly more accurate. The conclusions here are that no one theory could make adequate predictions of behavior, that purchase likelihood measures are a poor substitute for measuring actual behavior but that purchase probability scales should be used more often in adoption research.

Ontology learning from text: a soft computing paradigm

Text-based information accounts for more than 80% of today’s Web content. They consist of Web pages written in different natural languages. As the semantic Web aims at turning the current Web into a machine-understandable knowledge repository, availability of multilingual ontology thus becomes an issue at the core of a multilingual semantic Web. However, multilingual ontology is too complex and resource intensive to be constructed manually. In this paper, we propose a three-layer model built on top of a soft computing framework to automatically acquire a multilingual ontology from domain specific parallel texts. The objective is to enable semantic smart information access regardless of language over the Semantic Web.

Ontological engineering for conceptual modeling

In acknowledging the importance of ontologies in conceptual modeling, database integration and business process modeling, this paper introduces a set of principles for building ontologies. Starting from Guarino's meta-properties of ontological terms, the paper describes the denotational semantics of the meta-properties and derives from them some engineering rules and checks for constructing domain specific conceptual models, based on the overarching requirement to assign meanings to concepts using tags and labels. Parallel research by the authors into the use of contextual references and roles to restrict such meanings will be published elsewhere.

Capturing best practices in web development

This paper describes capturing design experiences by applying grounded theory to pattern mining. The presented approach aims at inducing expert development knowledge and its subsequent packaging into domain-specific design patterns, which could later be used by both experienced and novice developers in the field. The method was evaluated empirically in a domain of Web development.

A backward glance of who and what marketing scholars have been researching 1977-2002

Despite the diversity of all those involved within the marketing discipline, all have a stake in maximizing the advancement of marketing knowledge. Without a specific analysis it is difficult to reflect on where a field has been or where it might be heading. The purpose of this chapter is to examine who and what marketing scholars have been researching over the period 1977–2002 using content analysis. This chapter provides longitudinal benchmarking of the ‘‘inputs’’ (authors and institutions) and ‘‘outputs’’ (articles) examining the marketing literature in the four major marketing journals: the Journal of Marketing, the Journal of Marketing Research, the Journal of Consumer Research, and the Journal of the Academy of Marketing Science.

A new screen face for public service broadcasting

The contemporary broadcasting industry is characterised by technological and social change, it is increasingly competitive, and the media industry is fragmenting. New services need not necessarily compete with existing free-to-air broadcasting but could act as further incentive for audiences to invest in new equipment. New equipment will be necessary in the future as set out under the Television Broadcasting Services (Digital Conversion) Act 2000 (Cth), before the planned switch-off of analogue broadcasts planned for this year but now likely to be 2013. By then, however, audiences might already have migrated to the online environment for television and radio content as well as other services. Those that produce and deliver programs via free-to-air broadcasting need to consider what audiences do with new media in order to engage them. This will be an ongoing process as technology and audience expectations continue to change. Against such a background, this article examines how Australia’s public broadcasters are responding to the new media environment. It will consider their interactive online programs and services with specific analysis of ABC’s new ‘iView’ and ‘ABC Fora’ which offer content on-demand. It will also examine SBS online initiatives. I wish to argue that the new media offer public broadcasters new prospects to provide forums and spaces for education, entertainment, public discussion and interaction online.

Bioassay detects soluble MAdCAM-1 in body fluids

Mucosal addressin cell adhesion molecule (MAdCAM-1) is a key player in mediating the infiltration of leucocytes into chronically inflamed tissues. Five anti-MAdCAM-1 monoclonal antibodies (mAb), designated 17F5, 201F7, 314G8, 377D10 and 355G8, were generated by fusion of P3 × 63Ag8.653 myeloma cells with spleen cells from BALB/c mice immunized with recombinant human MAdCAM-1-Fc. The latter four mAb recognize the ligand-binding first Ig domain, and block T -cell adhesion to MAdCAM-1. The non-blocking mAb 17F5 recognizes the mucin domain. Extensive analysis of a large panel of paraffin-embedded human tissues revealed that the 314G8 mAb detected MAdCAM-1 on venules in the spleen and small intestine. MAdCAM-1 was strongly expressed in the synovium of osteoarthritis patients, predominantly on the endothelial lining of blood vessels, but also within the vessel lumen. An ELISA, based on mAb 377D10 and 355G8, was developed to determine whether soluble MAdCAM-1 was present in body fluids, and to measure the levels present. The assay detected soluble MAdCAM-1 in the serum and urine of healthy donors, at levels similar to those of soluble forms of the related CAM, ICAM-1 and VCAM-1. The anti-MAdCAM-1 antibodies and assay developed here may be useful therapeutically in the treatment of inflammation in humans. Similarly, they may be useful diagnostically to monitor the presence and levels of MAdCAM-1.

Evaluating and improving morpho-syntactic classification over multiple corpora using pre-trained, "off-the-shelf", parts-of-speech tagging tools

This paper evaluates six commonly available parts-of-speech tagging tools over corpora other than those upon which they were originally trained. In particular this investigation measures the performance of the selected tools over varying styles and genres of text without retraining, under the assumption that domain specific training data is not always available. An investigation is performed to determine whether improved results can be achieved by combining the set of tagging tools into ensembles that use voting schemes to determine the best tag for each word. It is found that while accuracy drops due to non-domain specific training, and tag-mapping between corpora, accuracy remains very high, with the support vector machine-based tagger, and the decision tree-based tagger performing best over different corpora. It is also found that an ensemble containing a support vector machine-based tagger, a probabilistic tagger, a decision-tree based tagger and a rule-based tagger produces the largest increase in accuracy and the largest reduction in error across different corpora, using the Precision-Recall voting scheme.

Evaluating and improving morpho-syntactic classification over multiple corpora using pre-trained, “off-the-shelf”, parts-of-speech tagging tools

his paper evaluates six commonly available parts-of-speech tagging tools over corpora other than those upon which they were originally trained. In particular this investigation measures the performance of the selected tools over varying styles and genres of text without retraining, under the assumption that domain specific training data is not always available. An investigation is performed to determine whether improved results can be achieved by combining the set of tagging tools into ensembles that use voting schemes to determine the best tag for each word. It is found that while accuracy drops due to non-domain specific training, and tag-mapping between corpora, accuracy remains very high, with the support vector machine-based tagger, and the decision tree-based tagger performing best over different corpora. It is also found that an ensemble containing a support vector machine-based tagger, a probabilistic tagger, a decision-tree based tagger and a rule-based tagger produces the largest increase in accuracy and the largest reduction in error across different corpora, using the Precision-Recall voting scheme.

Living with prostate cancer: randomised controlled trial of a multimodal supportive care intervention for men with prostate cancer

Background: Prostate cancer is the most common male cancer in developed countries and diagnosis and treatment carries with it substantial morbidity and related unmet supportive care needs. These difficulties may be amplified by physical inactivity and obesity. We propose to apply a multimodal intervention approach that targets both unmet supportive care needs and physical activity.

Methods/design: A two arm randomised controlled trial will compare usual care to a multimodal supportive care intervention “Living with Prostate Cancer” that will combine self-management with tele-based group peer support. A series of previously validated and reliable self-report measures will be administered to men at four time points: baseline/recruitment (when men are approximately 3-6 months post-diagnosis) and at 3, 6, and 12 months after recruitment and intervention commencement. Social constraints, social support, self-efficacy, group cohesion and therapeutic alliance will be included as potential moderators/mediators of intervention effect. Primary outcomes are unmet supportive care needs and physical activity levels. Secondary outcomes are domain-specific and healthrelated quality of life (QoL); psychological distress; benefit finding; body mass index and waist circumference. Disease variables (e.g. cancer grade, stage) will be assessed through medical and cancer registry records. An economic evaluation will be conducted alongside the randomised trial.

Discussion: This study will address a critical but as yet unanswered research question: to identify a populationbased way to reduce unmet supportive care needs; promote regular physical activity; and improve disease-specific and health-related QoL for prostate cancer survivors. The study will also determine the cost-effectiveness of the intervention.

A randomised trial of robotic and open prostatectomy in men with localised prostate cancer

Background
Prostate cancer is the most common male cancer in the Western world however there is ongoing debate about the optimal treatment strategy for localised disease. While surgery remains the most commonly received treatment for localised disease in Australia more recently a robotic approach has emerged as an alternative to open and laparoscopic surgery. However, high level data is not yet available to support this as a superior approach or to guide treatment decision making between the alternatives. This paper presents the design of a randomised trial of Robotic and Open Prostatectomy for men newly diagnosed with localised prostate cancer that seeks to answer this question.

Methods
200 men per treatment arm (400 men in total) are being recruited after diagnosis and before treatment through a major public hospital outpatient clinic and randomised to 1) Robotic Prostatectomy or 2) Open Prostatectomy. All robotic prostatectomies are being performed by one surgeon and all open prostatectomies are being performed by one other surgeon. Outcomes are being measured pre-operatively and at 6 weeks and 3, 6, 12 and 24 months post-surgery. Oncological outcomes are being related to positive surgical margins, biochemical recurrence +/ the need for further treatment. Non-oncological outcome measures include: pain, physical and mental functioning, fatigue, summary (preference-based utility scores) and domain-specific QoL (urinary incontinence, bowel function and erectile function), cancer specific distress, psychological distress, decision-related distress and time to return to usual activities. Cost modelling of each approach, as well as full economic appraisal, is also being undertaken.

Discussion
The study will provide recommendations about the relative benefits of Robotic and Open Prostatectomy to support informed patient decision making about treatment for localised prostate cancer; and to assist in treatment services planning for this patient group. Trial Registration ACTRN12611000661976

Assessing the impact of diabetes on the quality of life of older adults living in a care home : validation of the ADDQoL senior

Aims  Around a quarter of UK care-home residents have diabetes. Diabetes is known to impact quality of life but existing diabetes-specific quality of life measures are unsuitable for elderly care-home residents. We aimed to develop and evaluate a new measure for use with older adults, to be particularly suitable for use with care-home residents: the Audit of Diabetes-Dependent Quality of Life (ADDQoL) Senior†.

Methods  Content and format changes were made to the 19-domain ADDQoL, informed by related measures for people with visual impairments (12 domain-specific items were retained, four items were revised/added and three items were removed). This revision was modified further following cognitive debriefing interviews with three older adults living in a care home. Psychometric evaluation of the newly developed 17-domain ADDQoL Senior was conducted using data from 90 care-home residents with diabetes who took part in a broader intervention study.

Results  The life domains most impacted by diabetes were ‘independence’ and ‘freedom to eat as I wish’. The ADDQoL Senior demonstrated good factor structure and internal consistency (Cronbach’s alpha = 0.924). Domain scores were, as expected, significantly intercorrelated.

Conclusions  The ADDQoL Senior measures the perceived impact of diabetes on quality of life in older adults, and has been found to be suitable for those living in care homes if administered by interview. The scale has demonstrated acceptability and excellent psychometric properties. It is anticipated that the number of items may be reduced in the future if our current findings can be replicated.