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Purpose The purpose of this paper is to examine the state of French medium sized business schools in the Grandes Ecole sector of education and how networks and alliances help business schools survive in an ever-changing and global environment. Design/methodology/approach The material for empirical research for this paper was gathered by using a case study method of four small to medium sized provincial Institutions of Management Education in France. Findings The paper demonstrates that all of the business schools studied rely on networks and alliances to face globalisation and internationalise their strategy and seems to follow the three typologies of mergers and acquisitions set down by Napier (1989): extension mergers, collaborative mergers and redesign mergers. At present, the networks and alliances are used on a marginal or peripheral way by networking only a part of the institution at one time. Research limitations/implications Further research at a later date needs to be carried out in order to observe if the pattern will remain or if there may be networks which will start from the core of the institution since the organisations will in the future have more of an international or global culture. Originality/value The value of this paper is to demonstrate that medium-sized business schools can compensate their limited resources and compete in the global education market. Alliances and networks appear as key ways in achieving goals of sustainability and survival.

Background Poor retention in randomised trials can lead to serious consequences to their validity. Studies within trials (SWATs) are used to identify the most effective interventions to increase retention. Many interventions could be applied at any follow-up time point, but SWATs commonly assess interventions at a single time point, which can reduce efficiency. Methods The re-randomisation design allows participants to be re-enrolled and re-randomised whenever a new retention opportunity occurs (i.e. a new follow-up time point where the intervention could be applied). The main advantages are as follows: (a) it allows the estimation of an average effect across time points, thus increasing generalisability; (b) it can be more efficient than a parallel arm trial due to increased sample size; and (c) it allows subgroup analyses to estimate effectiveness at different time points. We present a case study where the re-randomisation design is used in a SWAT. Results In our case study, the host trial is a dental trial with two available follow-up points. The Sticker SWAT tests whether adding the trial logo’s sticker to the questionnaire’s envelope will result in a higher response rate compared with not adding the sticker. The primary outcome is the response rate to postal questionnaires. The re-randomisation design could double the available sample size compared to a parallel arm trial, resulting in the ability to detect an effect size around 28% smaller. Conclusion The re-randomisation design can increase the efficiency and generalisability of SWATs for trials with multiple follow-up time points.

Background Researchers often rely on trial participants to self-report clinical outcomes (for example, fractures, re-operations). Little information exists as to the ‘accuracy’ of participant-reported clinical outcomes, particularly in randomised controlled trials (RCTs). To help address this evidence gap, we report four case studies, nested within different RCTs where participant-reported clinical outcome data were compared with those reported by clinicians or extracted from medical notes. Methods Four publicly-funded RCTs with different methods of verifying participant-reported outcomes were identified. In KAT, the participants were asked about hospital admissions for any reason. Where it was thought to be relevant to the trial knee, further information was sought from the lead surgeon at the admitting site to confirm whether or not the admission was relevant to the trial knee. In REFLUX, participants were asked about hospital admissions for any reason. For participants who reported a re-operation, further information was sought from the lead surgeon at the admitting site to confirm this. In RECORD, participants were asked three questions regarding broken bones. Where low-trauma fractures were reported, clinical verification was sought, initially from the research nurse at the site. In CATHETER, participants were asked about urinary tract infections (UTIs), and a prescription of antibiotics was provided for the treatment of UTIs following urethral catheterisation. The GPs of those who reported a UTI were contacted to confirm that an antibiotic prescription had been issued for the suspected UTI. Results In KAT, 397 of 6882 (6%) participant-reported hospital admissions were confirmed as relevant to the trial knee. In REFLUX, 16 of 19 participants (84%) who appeared to have had a re-operation were confirmed as having had one. In RECORD, 473 of 781 (61%) fractures reported by participants were confirmed as being low-trauma fractures. In CATHETER, 429 of 830 participant-reported UTIs (52%) were confirmed as such by the GPs. Conclusions We used different approaches in our verification of participant-reported outcomes in clinical trials, and we believe there is no one optimal solution. Consideration of issues such as what information is sought from participants, the phrasing of questions, whether the medical records are a true ‘gold standard’ and costs and benefits to the RCT may help determine the appropriate approach.

Background Data collection consumes a large proportion of clinical trial resources. Each data item requires time and effort for collection, processing and quality control procedures. In general, more data equals a heavier burden for trial staff and participants. It is also likely to increase costs. Knowing the types of data being collected, and in what proportion, will be helpful to ensure that limited trial resources and participant goodwill are used wisely. Aim The aim of this study is to categorise the types of data collected across a broad range of trials and assess what proportion of collected data each category represents. Methods We developed a standard operating procedure to categorise data into primary outcome, secondary outcome and 15 other categories. We categorised all variables collected on trial data collection forms from 18, mainly publicly funded, randomised superiority trials, including trials of an investigational medicinal product and complex interventions. Categorisation was done independently in pairs: one person having in-depth knowledge of the trial, the other independent of the trial. Disagreement was resolved through reference to the trial protocol and discussion, with the project team being consulted if necessary. Key results Primary outcome data accounted for 5.0% (median)/11.2% (mean) of all data items collected. Secondary outcomes accounted for 39.9% (median)/42.5% (mean) of all data items. Non-outcome data such as participant identifiers and demographic data represented 32.4% (median)/36.5% (mean) of all data items collected. Conclusion A small proportion of the data collected in our sample of 18 trials was related to the primary outcome. Secondary outcomes accounted for eight times the volume of data as the primary outcome. A substantial amount of data collection is not related to trial outcomes. Trialists should work to make sure that the data they collect are only those essential to support the health and treatment decisions of those whom the trial is designed to inform.

Background Multicentre randomised trials provide some of the key evidence underpinning healthcare practice around the world. They are also hard work and generally expensive. Some of this work and expense are devoted to sites that fail to recruit as many participants as expected. Methods to identify sites that will recruit to target would be helpful. Methods We asked trial managers at the Centre for Healthcare Randomised Trials (CHaRT), University of Aberdeen to predict whether a site would recruit to target. Predictions were made after a site initiation visit and were collected on a form comprising a simple ‘Yes/No’ prediction and a reason for the prediction. We did not provide guidance as to what trial managers might want to think about when making predictions. After a minimum of eight months of recruitment at each site for which a prediction had been made, all trial mangers in CHaRT were invited to a group discussion where predictions were presented together with sites’ actual recruitment performance over that period. Individual trial managers reflected on their predictions and there was a general discussion about predicting site recruitment. The prediction reasons from the forms and the content of the group discussion were used to identify features linked to correct predictions of recruitment failure. Results Ten trial managers made predictions for 56 site visits recruiting to eight trials. Trial managers’ sensitivity was 82% and their specificity was 32%, correctly identifying 65% of sites that would hit their recruitment target and 54% of those that did not. Eight ‘red flags’ for recruitment failure were identified: previous poor site performance; slow approvals process; strong staff/patient preferences; the site recruitment target; the trial protocol and its implementation at the site; lack of staff engagement; lack of research experience among site staff; and busy site staff. We used these red flags to develop a guided prediction form. Conclusions Trial managers’ unguided recruitment predictions were not bad but were not good enough for decision-making. We have developed a modified prediction form that includes eight flags to consider before making a prediction. We encourage anyone interested in contributing to its evaluation to contact us.

They are up to it again. Making something new. Doing something different. Creating crazy acronyms - MBIE or MOBIE (Ministry of Business Innovation and Employment), CRAP (Child Research Action Plan). Yes really. And now its SuPERU. What is that about?

IntroductionBladder cancer is the most frequently occurring tumour of the urinary system. Ta, T1 tumours and carcinoma in situ (CIS) are grouped as non-muscle invasive bladder cancer (NMIBC), which can be effectively treated by transurethral resection of bladder tumour (TURBT). There are limitations to the visualisation of tumours with conventional TURBT using white light illumination within the bladder. Incomplete resections occur from the failure to identify satellite lesions or the full extent of the tumour leading to recurrence and potential risk of disease progression. To improve complete resection, photodynamic diagnosis (PDD) has been proposed as a method that can enhance tumour detection and guide resection. The objective of the current research is to determine whether PDD-guided TURBT is better than conventional white light surgery and whether it is cost-effective.Methods and analysisPHOTO is a pragmatic multicentre randomised controlled trial (open parallel group, non-masked and superiority trial) comparing the intervention of PDD-guided TURBT with standard white light resection in newly diagnosed intermediate and high risk NMIBC within the UK National Health Service setting. Clinical effectiveness is measured with time to recurrence. Cost-effectiveness is assessed within trial via the calculation of incremental cost per recurrence avoided and incremental cost per quality-adjusted life per year gained over 3 years and over long term through a modelling exercise over patients’ lifetime.Ethics and disseminationFormal ethics review was undertaken with a favourable opinion, in line with UK regulatory procedures (REC reference number: 14/NE/1062). If reductions in time to recurrence is associated with long-term patient benefits, the cost-effectiveness evaluation will provide further evidence to inform adoption of the technology. Findings will be shared in lay media such as patient and charity forums and will be presented at key meetings and published in academic literature.Trial registration number ISRCTN84013636.

Objectives: Femoroacetabular impingement (FAI) is a condition that affects young athletes who participate in high impact activities. Patients often experience gradually worsening hip and/or groin pain, and thus have months to years of symptoms before choosing to undergo hip arthroscopy to correct the bony and soft tissue pathology. Patients undergoing surgery usually report that they are pursuing surgery for pain relief and expect to be able to return to their previous level of activity. An athlete’s ability to return to their previous level of sport depends not only on their physical ability, but their psychological ability as well. Because patients often experience months to years of symptoms before surgery, this group is particularly vulnerable to kinesiophobia, pain catastrophizing, and other psychological factors that may influence recovery and overall return to physical activity. The Hip-Return to Sport after Injury (Hip-RSI) scale is a validated tool used to assess an athlete’s psychological readiness to return to sport and specifically looks at emotions, confidence, and risk appraisal in relation to a patient’s perception of hip function and is positively associated with return to sport (RTS). Recovery and RTS is not a linear process, as an athlete’s psychological readiness likely changes over time. However, this potential change in readiness throughout the recovery process has not yet been described. This study primarily aimed to describe the change in Hip-RSI in patients who undergo hip arthroscopy for FAI. A secondary objective was to examine the relationship between Hip- RSI and patient satisfaction with hip function, patient expectations of recovery timeline, patient expectations to return to sport, and history of anxiety/depression. Methods: A single surgeon’s prospectively collected Hip Database was used to obtain a comprehensive patient list. This study was conducted under the IRB approval of the Hip Database. Patients were included if they underwent a hip arthroscopy and completed the Hip-Return to Sport after Injury questionnaire (Hip-RSI) at minimum one of four postoperative timepoints: 3 months, 6 months, 1 year and 2 years. One hundred and fifty patients had a completed Hip-RSI score at at least one of these timepoints. Additional variables included BMI, diagnosis codes, patient satisfaction and expectations, history or presence of anxiety/depression, and other patient reported outcomes (PROs), including iHOT-12, HOS-ADL and HOS-SSS. There were four patient satisfaction and expectations questions patients answered in their questionnaire, three of which were yes/no questions, and one was a slider scale from 0-10 that pertained to hip function satisfaction. A chart review was performed to determine the BMI, diagnosis codes, and history/presence of history of anxiety/depression for patients who did not have this data in the Hip Database. A Mann Whitney U test and Pearson correlation tests were performed to determine averages and correlations between Hip-RSI and the history/presence of anxiety/depression and satisfaction and expectations. Results: The average age of this population was 30 ± 13 years, with an average BMI of 25.8 ± 5.7, and an average duration of symptoms for 24.7± 22.6 months. Hip-RSI scores were determined for each of the four timepoints, which showed that there was an increase in Hip-RSI scores from 3 months to 1 year postoperatively, and an almost a 10-point decrease at 2 years postoperatively, as shown in Table 1. There was no significant difference in Hip-RSI in patients with a history of anxiety and/or depression at any of the four timepoints. There were no significant correlations between Hip-RSI and any other variables or outcome measures at two years postoperatively. At 3 months, 6 months, and 12 months postoperatively, Hip-RSI had a strong, positive correlation with a patient’s self-reported satisfaction level of their current hip function (p<0.001). The averages of Hip-RSI and this patient satisfaction question are shown in Table 2. Two other patient expectation questions were also positively correlated with Hip-RSI at various timepoints, as shown in Figure 1. Hip-RSI had a strong correlation with three other PROs: iHOT-12, HOS-ADL, and HOS-SSS at all three timepoints (p<0.001). The only exceptions were two moderative, positive correlations between Hip-RSI and HOS-ADL, as well as between Hip-RSI and HOS-SSS, at 3 months postoperatively. Conclusions: Based on our findings, a patient’s psychological readiness for return to sport changes over time, with an increase in readiness up to 1 year postoperatively, and a decrease in readiness at two years postoperatively. While history or presence of anxiety and/or depression does not influence Hip-RSI scores, patient satisfaction and expectations after a hip arthroscopy appears to influence it, however further investigation is required.

Our aim was to design and evaluate a novel behavior change approach to increase response rates to an annual postal questionnaire in three randomized studies within a trial (SWAT) and replicate the most promising SWAT. SWAT1 tested a trial logo sticker on questionnaire envelopes vs. no sticker; SWAT2 tested a theoretically informed letter sent with the questionnaire vs. a standard letter; SWAT3 tested a theoretically informed newsletter sent before the questionnaire vs. no newsletter. The SWATs were conducted within a large dental trial (N = 1,877 adults), and SWAT2 replicated in a different trial in a similar setting (N = 2,372). SWAT1 improved response rates by 1.4%, 95% confidence interval (CI) (−7.2%, 10.0%). SWAT2 improved response rates by 7.0%, 95% CI (1.7%, 12.3%). SWAT3 improved response rates by 0.8%, 95% CI (−5.1%, 6.7%). Replication of SWAT2 as the most promising SWAT showed improvement in response rates of 1.0%, 95% CI (−3.2%, 5.3%). Pooled results from SWAT2 showed an overall improvement in response rates of 3.4%, 95% CI (0.1%, 6.7%). A theory-based behavioral approach to design interventions to improve trial response rates showed small but meaningful improvements. The approach presented here can be easily implemented and adapted to address other identified barriers to trial retention.