5 research outputs found
Multicentre study of 10,369 symptomatic patients comparing the diagnostic accuracy of colon capsule endoscopy, colonoscopy and CT colonography
No full textBackground
During the COVID-19 pandemic, NHS England introduced colon capsule endoscopy (CCE) at scale to support the recovery of endoscopy. Symptomatic patients referred with suspected colorectal cancer (CRC) and a faecal immunochemical test (FIT) ≤ 100 μg Hb/g faeces were offered CCE.
Aims
To evaluate the safety, diagnostic accuracy and utility of CCE in this setting.
Methods
Consenting patients, referred on a suspected CRC pathway with FIT ≤ 100 μg Hb/g faeces, were offered CCE, colonoscopy or CT colonography. Each cohort was to be age-, sex-, symptom- and FIT-matched. We performed a paired comparison of findings in those who required colorectal endoscopy after CCE and recorded clinical outcomes.
Results
We recruited 4878 patients for CCE, 5025 for colonoscopy and 466 for CT colonography patients. CCE was safely tolerated by 98.4% of patients. CCE identified a matched mass lesion in all patients with CRC when the examination was complete and adequately prepared. More polyps ≥ 10 mm and 6–9 mm were detected by CCE than by colonoscopy or CT colonography. Per-patient sensitivities for polyps ≥ 10 mm and 6–9 mm were 97% in those with a paired, complete and adequately prepared CCE than colonoscopy. Completion (74%) and bowel preparation adequacy rates (74%) were poorer than those of colonoscopy and CTC (both 88%). However, CCE usefully performed a filter function in 86% of patients.
Conclusions
CCE is safe and accurate for the diagnosis of colorectal disease. In the suspected CRC pathway, its ‘filter function’ complements existing colorectal diagnostic services by creating additional capacity
Human resource management
No full textThis chapter explores the field of Human Resource Management (HRM) in Greece. Greece suffers from high unemployment rates, low demand for labour, and by a severe problem in creating high-skill and new technologically-oriented jobs (Karasiotou 2004; Staikouras 2004; National Statistical Service of Greece 2005). These factors precondition the Greek market in being one of limited investment and expansion opportunities (Eurostat 2008), while businesses are characterised by their small size (micro enterprises): 54.6 per cent of all registered businesses are owner only and 43.7 per cent employ from 1-10 employees, while large organisations (250+ employees) only account for a meagre 0.05 per cent of all registered businesses in the Greek market (National Statistical Service of Greece 2002). With an average organisational size of two employees per company, businesses in Greece can be characterised as very small in comparison to the EU average (Galanaki and Papalexandris 2007). However, the Greek economy significantly depends on the operation of micro enterprises. The share in total employment of micro enterprises in Greece accounts for 59.6 per cent, in comparison to an EU-27 average of 29.5 per cent, while the share in total value added in the economy by micro enterprises accounts for 38.6 per cent, in comparison to an EU-27 average of 20.2 per cent (Eurostat 2008). In addition, since the Greek economic environment is characterised by low government and business efficiency, low competitiveness, and low attraction of foreign direct investment (FDI), this leads to lower levels of investment and presence of MNCs in the market (for example, Haritakis and Pitelis 1998; Joumard and Mylonas 1999; Staikouras 2004).
At several points throughout this chapter, a discussion on the differences in HRM practices between small-medium-large Greek firms and MNCs will take place. This discussion is essential in order to illustrate the differences in HRM practices in MNCs, large Greek organisations, and small/medium-sized Greek firms, since it is micro enterprises (up to 10 employees) that constitute the majority of enterprises in the country, while large Greek firms and MNCs only constitute a meagre minority.
The chapter explores HRM practices in Greece by, firstly, providing a brief historical overview of the HR function in order to provide the necessary background to the reader to understand the current state of HRM in Greece. Secondly, it highlights issues relating the supply and demand for labour in the Greek labour market in order to illustrate organisational HR structures. Thirdly, it explores the Greek HR department and HR managers so that the particularities affecting the size and role of the department, as well as the level of professionalism of managers are understood. Fourthly, it provides an overview of the core HR activities (recruitment and selection, performance management and appraisals, training and development, employee rewards, and employee relations). Fifthly, the practice of outsourcing HR activities to external providers is discussed, as this is common practice for many Greek organisations. Sixthly, an overview of the use of e-HR is provided, as this is one of the latest developments in the field. Finally, two critical issues in HRM are explored; the ageing workforce and gender equality in the Greek workplace.
[Author's description
ColoCap: determining the diagnostic accuracy of colon capsule endoscopy compared with standard colonoscopy in patients at risk of colorectal disease – a study protocol
No full textBackground: Lower gastrointestinal symptoms attributed to colorectal disease are common. Early diagnosis of serious colorectal disease such as colorectal cancer (CRC), precancerous growths (polyps) and inflammation is important to ensure the best possible outcomes for a patient. The current ‘gold standard’ diagnostic test is colonoscopy. Colonoscopy is an invasive procedure. Some people struggle to cope with it and require intravenous sedation and/or analgesia. It is also resource-intensive, needing to be performed in specialist endoscopy units by a trained team. Across the UK, the demand for colonoscopy is outstripping capacity and the diagnosis of colorectal disease is being delayed. A colon capsule endoscope (CCE) is an alternative colorectal diagnostic. It is a ‘camera in a pill’ that can be swallowed and which passes through the gastrointestinal tract, obtaining visual images on the colon. There is now established experience of CCE in the UK. CCE might provide a less invasive method to diagnose colorectal disease if found to be accurate and effective and provide a means by which to increase the National Health Service (NHS) diagnostic capacity. Aims and objectives: The aim of this study is to determine the diagnostic accuracy of CCE when compared with colonoscopy in representative and clinically meaningful cohorts of patients. An evaluation of the experiences of CCE for the patient and clinical team and an assessment of cost effectiveness will be undertaken. Methods: We will undertake three research workstreams (WS). In WS1, we shall perform a paired (back-to-back) study. Each participant will swallow the CCE and then later on the same day they will have a colonoscopy. The study has been designed in collaboration with our Patient Advisory Group and as closely mirrors standard care as is possible. 973 participants will be recruited from three representative clinical contexts; suspected CRC, suspected inflammatory bowel disease and postpolypectomy surveillance. Up to 30 sites across the UK will be involved to maximise inclusivity. Measures of diagnostic accuracy will be reported along with CCE completion rates, number of colonoscopy procedures potentially prevented and adverse events, such as capsule retention. A nested substudy of intraobserver and interobserver agreement will be performed. WS2 will develop models of cost-effectiveness and WS3 will evaluate the patient and clinician experience, with reference to acceptability and choice. Anticipated impact: The study findings will provide the evidence base to inform future colorectal diagnostic services. Ethics and dissemination: The study has approval from the North East—Tyne and Wear South research ethics committee (REC reference 24/NE/0178, IRAS 331349). The findings will be disseminated to the NHS, National Institute for Health and Care Excellence, other clinical stakeholders and participants, patients and the public. Trial registration number: ISRCTN16126290
Feasibility of reporting results of large randomised controlled trials to participants:experience from the Fluoxetine or Control under supervision (FOCUS) trial
No full textObjectives: Informing research participants of the results of studies in which they took part is viewed as an ethical imperative. However, there is little guidance in the literature about how to do this. The Fluoxetine or Control Under Supervision Trial (FOCUS) randomised 3127 patients with a recent acute stroke to six months of fluoxetine or placebo and was published in Lancet on 5th December 2018. The trial team decided to inform the participants of the results at exactly the same time as the Lancet publication, and also whether they had been allocated fluoxetine or placebo. In this report, we describe how we informed participants of the results. Design. In the 6 month and 12 month follow-up questionnaires, we invited participants to provide an email address if they wished to be informed of the results of the trial. We re-opened our trial telephone helpline between 5th December 2018 and 31st March 2019. Setting: UK Stroke servicesParticipants: 3127 participants were randomised. 2847 returned 6 month follow-up forms and 2703 returned 12 month follow-up forms; the remaining participants had died (380), withdrawn consent or did not respond.ResultsOf those returning follow-up questionnaires, a total of 1845 email addresses were provided and a further 50 people requested results to be sent by post. Results were sent to all email and postal addresses provided; 309 emails were returned unrecognised. Seventeen people replied, of whom three called the helpline and the rest responded by email. ConclusionIt is feasible to disseminate results of large trials to research participants, though only around 60% of those randomised wanted to receive the results. The system we developed was efficient and required very little resource-and could be replicated by trialists in the future. <br/
Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial
No full textBackground
Results of small trials indicate that fluoxetine might improve functional outcomes after stroke. The FOCUS trial aimed to provide a precise estimate of these effects.
Methods
FOCUS was a pragmatic, multicentre, parallel group, double-blind, randomised, placebo-controlled trial done at 103 hospitals in the UK. Patients were eligible if they were aged 18 years or older, had a clinical stroke diagnosis, were enrolled and randomly assigned between 2 days and 15 days after onset, and had focal neurological deficits. Patients were randomly allocated fluoxetine 20 mg or matching placebo orally once daily for 6 months via a web-based system by use of a minimisation algorithm. The primary outcome was functional status, measured with the modified Rankin Scale (mRS), at 6 months. Patients, carers, health-care staff, and the trial team were masked to treatment allocation. Functional status was assessed at 6 months and 12 months after randomisation. Patients were analysed according to their treatment allocation. This trial is registered with the ISRCTN registry, number ISRCTN83290762.
Findings
Between Sept 10, 2012, and March 31, 2017, 3127 patients were recruited. 1564 patients were allocated fluoxetine and 1563 allocated placebo. mRS data at 6 months were available for 1553 (99·3%) patients in each treatment group. The distribution across mRS categories at 6 months was similar in the fluoxetine and placebo groups (common odds ratio adjusted for minimisation variables 0·951 [95% CI 0·839–1·079]; p=0·439). Patients allocated fluoxetine were less likely than those allocated placebo to develop new depression by 6 months (210 [13·43%] patients vs 269 [17·21%]; difference 3·78% [95% CI 1·26–6·30]; p=0·0033), but they had more bone fractures (45 [2·88%] vs 23 [1·47%]; difference 1·41% [95% CI 0·38–2·43]; p=0·0070). There were no significant differences in any other event at 6 or 12 months.
Interpretation
Fluoxetine 20 mg given daily for 6 months after acute stroke does not seem to improve functional outcomes. Although the treatment reduced the occurrence of depression, it increased the frequency of bone fractures. These results do not support the routine use of fluoxetine either for the prevention of post-stroke depression or to promote recovery of function.
Funding
UK Stroke Association and NIHR Health Technology Assessment Programme
