1,139 research outputs found
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 randomised 3127 patients with a recent acute stroke to 6 months of fluoxetine or placebo and was published in the Lancet on 5 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 5 December 2018 and 31 March 2019.Setting: UK stroke services.Participants: 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returned 6-month follow-up forms and 2703 returned 12-month follow-up forms; the remaining participants had died (380), withdrawn consent or did not respond.Results: of those returning follow-up questionnaires, a total of 1845 email addresses were provided and a further 50 people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.Conclusion: it 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.</div
Participants' preference for type of leaflet used to feed back the results of a randomised trial: a survey
No full textBackground\ud
Hundreds of thousands of volunteers take part in medical research, but many will never hear from researchers about what the study revealed. There is a growing demand for the results of randomised trials to be fed back to research participants both for ethical research practice and for ensuring their co-operation in a trial. This study aims to determine participants' preferences for type of leaflet (short versus long) used to summarise the findings of a randomised trial; and to test whether certain characteristics explained participants' preferences. \ud
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Methods\ud
553 participants in a randomised trial about General Practitioners' access to Magnetic Resonance Imaging for patients presenting with suspected internal derangement of the knee were asked in the final follow-up questionnaire whether they would like to be fed back the results of the trial. Participants who agreed to this were included in a postal questionnaire survey asking about their preference, if any, between a short and a long leaflet and what it was about the leaflet that they preferred. Multinomial logistic regression was used to test whether certain demographics of responding participants along with treatment group explained whether a participant had a preference for type of leaflet or no preference. \ud
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Results\ud
Of the participants who returned the final follow-up questionnaire, 416 (88%) agreed to receive the results of the trial. Subsequently 132 (32%) participants responded to the survey. Most participants preferred the longer leaflet (55%) and the main reasons for this were the use of technical information (94%) and diagrams (89%). There was weak evidence to suggest that gender might explain whether participants have a preference for type of leaflet or not (P = 0.084). \ud
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Conclusions\ud
Trial participants want to receive feed back about the results and appear to prefer a longer leaflet. Males and females might require information to be communicated to them differently and should be the focus of further research. \ud
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Experiences of running a stratified medicine adaptive platform trial : Challenges and lessons learned from 10 years of the FOCUS4 trial in metastatic colorectal cancer
No full textFunding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: FOCUS4 was co-funded by the Medical Research Council (MRC)/National Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation (EME) Programme and Cancer Research UK (CRUK) in April 2013. A subsequent AstraZeneca educational grant in 2017 funded the translational aspects of FOCUS4-C. Supply and distribution of AZD8931 for FOCUS-D and AZD1775 for FOCUS4-C were provided by AstraZeneca Ltd. Supply and distribution of aspirin and placebo for FOCUS4-B were provided by Bayer. The MRC Clinical Trials Unit at UCL receives core funding from the MRC within UK Research and Innovation (UKRI) (Budget: MC_UU_12023/20).Peer reviewe
Discourse on formation of investigators’ competencies
No full textOne of the most important aims of law enforcement agencies is crime investigation and
prevention. Consequently, one of the main activities of the law enforcement agencies, especially in the
pre-trial investigation sphere, is to optimise the organisation of the pre-trial investigation in order to
save the experienced skilled and competent specialists. The author of this research offers a new
approach and analyses the qualification and competence of the pre-trial investigation subjects not only
in terms of personnel management, but all elements of the model of pre-trial investigation to make
pre-trial investigation organisation more effective. It should be noted that the content of an
investigators‘ qualification or levels of competence are still not determined or strictly regulated and
this is the reason for many discussions in this area. These discussions surround what qualification and level of competence the investigators should have in pre-trial investigation, what general and special
competencies they should acquire and how the content of the competencies should be determined. In the present article the author analyses the investigators‘ qualification and competence as a
presumption that it is an essential aspect of an effective pre-trial investigation. Analysing this question
the author compares other subjects such as the regulation of qualifications and levels of competence of
the prosecutors and pre-trial investigation judges. The author also identifies the problem of how to
define an investigators qualification and level of competence making recommendations to create a
Description of Investigators Competencies. Qualification requirements should be determined in this
legal act and general, occupational and special competencies should be identified with the content also
being determined within this framework. Formation of the Description of Investigators‘ Competencies
should determine not only the content of the investigators‘ required level of competence but also this
process should be consistent with the assessment and career development of investigators‘ including
the process of gaining the investigators‘ qualification. The aim of this research is to identify the problems associated with defining an investigators‘
qualification and levels of competence and to propose recommendations on how this could be
achieved. The subject of this research is limited to only looking at investigators‘ qualification and
level of competence. The author is using a qualitative method for this research based upon the contents of documents.
The author will analysis eight legal acts related to the qualification and competence of pre-trial
investigation and fifty different investigators‘ job descriptions.Straipsnyje nagrinėjama ikiteisminio tyrimo pareigūnų (tyrėjų) kvalifikacija ir kompetencija kaip viena iš veiksmingo ikiteisminio tyrimo organizavimo prielaidų. Analizuojant tyrėjų kvalifikacijos ir kompetencijos turinį ir jo reglamentavimą, lyginama kitų ikiteisminio tyrimo subjektų – prokurorų ir ikiteisminio tyrimo teisėjų – kvalifikacijos ir kompetencijos turinio reglamentavimo ypatumai, identifikuojamos tyrėjų kvalifikacijos ir kompetencijos apibrėžties problemos ir pateikiami sprendimo būdai – siūlomas ikiteisminio tyrimo pareigūnų (tyrėjų) kompetencijų aprašas, kuriame būtų tiksliai nustatyti tyrėjų kvalifikaciniai reikalavimai, identifikuotos bendrosios, profesinės ir specialiosios kompetencijos ir apibrėžtas šių kompetencijų turinys. Ikiteisminio tyrimo pareigūnų kompetencijų aprašo suformavimas sudarytų galimybę ne tik aiškiai apibrėžti tyrėjo kompetencijos turinį, bet ir šį procesą nuosekliai susieti su tyrėjo veiklos vertinimu, karjera ir kvalifikacijos tobulinimu. Straipsnį sudaro įvadas ir dvi dalys. Pirmoje dalyje nagrinėjama tyrėjo kvalifikacijos apibrėžties problematika, gretinama ikiteisminio tyrimo pareigūno, prokuroro ir teisėjo kvalifikacijos apibrėžtys. Šioje dalyje siūloma tiksliai nustatyti ir apibrėžti tyrėjo kvalifikacinius reikalavimus. Antrojoje dalyje analizuojama tyrėjo kompetencijos turinys. Nagrinėjant prokurorų, teisėjų kompetencijos turinį ir jo reglamentavimo ypatumus, siūloma sudaryti tyrėjo kompetencijų aprašą, kuriame būtų tiksliai apibrėžtas tyrėjo kompetencijos turinys
Thrombolysis is associated with consistent functional improvement across baseline stroke severity: a comparison of outcomes in patients from the Virtual International Stroke Trials Archive (VISTA)
No full text<p><b>Background and Purpose:</b> Baseline stroke severity predicts outcomes among thrombolysed patients. The baseline National Institutes of Health Stroke Scale (NIHSS) thresholds are sometimes used to select patients for thrombolysis, clinical trial enrollment, or both. Using data lodged with Virtual International Stroke Trials Archive, we compared adjusted outcomes between thrombolysed and nonthrombolysed patients enrolled in neuroprotection trials (1998-2007) to assess the influence of various levels of baseline NIHSS.</p>
<p><b>Method:</b> We assessed the association of treatment with outcome, measured across the modified Rankin scale score distribution, in patients categorized by baseline NIHSS in increments of 4. We used an age and baseline NIHSS adjusted Cochran-Mantel-Haenszel test followed by proportional odds logistic regression analysis. We report the Cochran-Mantel-Haenszel P values and estimated odds ratios (OR) for improved modified Rankin scale score distribution with treatment for patients within each baseline NIHSS category.</p>
<p><b>Results:</b> Data were available for 5817 patients (1585 thrombolysed and 4232 nonthrombolysed). Baseline severity was greater among thrombolysed than nonthrombolysed (median baseline NIHSS, 14 vs 13; P<0.05). An association of treatment with outcome was seen independently and was of similar magnitude within each of the baseline NIHSS categories 5 to 8 (P=0.04; OR, 1.25; 95% confidence interval [CI], 1.0-1.6; N=278/934 thrombolysed/nonthrombolysed), 9 to 12 (P=0.01; OR, 1.3; 95% CI, 1.1-1.6; N=404/942), 13 to 16 (P<0.05; OR, 1.6; 95% CI, 1.3-2.1; N=342/814), 17 to 20 (P<0.05; OR, 1.7; 95% CI, 1.3-2.1; N=311/736), and 21 to 24 (P<0.05; OR, 1.6; 95% CI, 1.1-2.1; N=178/466). No association was observed within baseline NIHSS categories 1 to 4 (P=0.8; OR, 1.1; 95% CI, 0.3-4.4; N=8/161) or >= 25 (P=0.08; OR, 1.1; 95% CI, 0.7-1.9; N=64/179).</p>
<p><b>Conclusions:</b> In this nonrandomized comparison, outcomes after thrombolysis were significantly better than in untreated comparators across baseline NIHSS 5 to 24. The significant association was lost only at extremes of baseline NIHSS when sample sizes were small and confidence limits were wide.</p>
Non-valvular atrial fibrillation and stroke : implications for management
No full textNonvalvular Atrial Fibrillation is more prevalent with increasing age. It is associated with a six-fold excess risk of stroke; and a cumulative lifetime stroke risk of 35%. 15% of ischaemic strokes are directly attributable to it. Five trials have established the safety of warfarin in reducing the risk by 70% in well selected patients, with stringent monitoring. Thromboembolism, cardiac failure, hypertension and echocardiographic abnormalities identify higher risk patients. The management of NVAF is changing from rate control, to cardioversion and anticoagulation (or use of antithrombotics) to reduce the embolic risk.peer-reviewe
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Professionalising counter fraud specialists (fraud investigators) in the UK public sector: a focus upon Department for Work and Pensions, National Health Service and the Local Authority
No full textThis thesis seeks to examine and explore the professionalisation initiatives of the UK public sector counter fraud specialists (fraud investigators), with a focus upon the Department for Work and Pensions (DWP), National Health Service (NHS) and Local Authority (LA). The conceptual framework used to underpin the study was functionalist / “traits” theory of a profession and professionalisation. The main research question for the thesis concerns the issue of whether counter fraud specialism is a profession or not. Thus the question here is: “Is counter fraud specialism a profession or not?”. Additionally, the thesis seeks to answer the question on how to develop a profession of counter fraud specialists. Thus, the question here is “If we want to develop a profession of counter fraud specialists (CFS), how do we do it?”. Fraud is a growing problem in UK which affects the government, businesses, individuals and society as a whole, and much more than would be assumed by anyone suggesting it to be a victimless crime. Despite this, the reputation of UK public sector fraud investigators had in the past gained negative images resulting from the use of questionable investigative practices, together with the lack of appropriate mechanism for evaluating the training of fraud investigators, and the ease of defrauding the welfare system
Cooperation between investigators and prosecutors in pre-trial investigation: investigators’ viewpoint
No full textNowadays, it would be difficult to imagine a person investigating a case individually, without coordination of actions with other subjects, especially when complex, multi-episodic cases are investigated. The efficiency of solved crimes, investigation and prevention partly depends on cooperation between prosecutors and investigators. The work of the subjects in crime investigation is multiple; therefore, it is necessary to coordinate reciprocal understanding between them. The Code of Criminal Procedure raises doubts and discussions about cooperation between prosecutors and investigators. In juridical literature, much information on cooperation among pre-trial officers exists. However, the practical question of cooperation between an investigator and a prosecutor has not yet received sufficient attention. Therefore, the main purpose of this article is to examine the pre-trial investigators’ attitude to cooperation between prosecutors and investigators, to single out the main forms of cooperation, and to make suggestions for more effective cooperation. The article deals with an empirical research done by the author in the form of a questionnaire, in which pre-trial investigators from national police institutions were questioned about the problems of cooperation between prosecutors and investigators. The research revealed the pre-trial investigators’ attitude to cooperation between prosecutors and investigators. According to the results of the research, cooperation among prosecutors and investigators is insufficient and formal. It is evident that it is necessary to pay attention to the content and forms of cooperation between prosecutors and investigators as well as to solve the problem of establishing juridical regulation regarding this institution. The data show that the intensity of emotional destructiveness has an impact on other differences among murders, especially the motivational factors for murderers to commit the crime and how these murders were committed. Offenders with a high level of emotional destructiveness tended to commit murders because of “an explosion” of their destructive emotions. The data show that clear differences among murderers possessing high or low emotional destructiveness can already be observed in their childhood and adolescence years. The data also show essential differences among murderers in their personality traits and attitude towards life. A possible use of the results of this study to improve criminal legislation and crime prevention are discussed in the article. The article shows that data provide new prospects in making criminal legislation and crime prevention more individualistic.Dabartiniu metu, ko gero, būtų sunku įsivaizduoti ikiteisminio tyrimo bylą tiriančio asmens darbą be jo veiksmų suderinamumo su kitais subjektais, ypač tiriant sudėtingas, daugiaepizodines, didelės apimties ikiteisminio tyrimo bylas. Nusikalstamų veikų atskleidimo, ištyrimo bei užkardymo efektyvumas tam tikru aspektu priklauso ir nuo tyrėjo bendradarbiavimo su prokuroru, specialistu. Tik teisingai organizuojant bendradarbiavimo procesą galima užtikrinti, kad tiriant nusikalstamas veikas būtų išnaudoti visi galimi tinkamiausi būdai ir pasirinkti tinkami subjektų veiklos koordinavimo metodai, siekiant ištirti nusikaltimą. Subjektų veikla atskleidžiant ir tiriant nusikalstamas veikas yra daugialypė, o tai reikalauja tarpusavio veiksmų suderinamumo. Bendradarbiavimo samprata, principai, formos ilgą laiką buvo nagrinėjami kaip kriminalistikos taktikos bendrosios dalies teiginiai, kurie vėliau laipsniškai išaugo į gana plačią, ir teoriniu, ir praktiniu požiūriu aktualią sistemą. Todėl dabartiniu metu šis klausimas kelia daug diskusijų, nes atskirų mokslininkų nuomonės dėl bendradarbiavimo instituto nesutampa. Diskutuojama apie keturnarę arba penkianarę kriminalistikos mokslo sistemą: bendradarbiavimas yra kriminalistikos taktikos elementas, ar penktosios kriminalistikos mokslo sistemos dalies – ikiteisminio tyrimo organizavimo – sudėtinis elementas. Lietuvos Respublikos baudžiamojo proceso kodeksas sukėlė naujų diskusijų apie ikiteisminio tyrimo pareigūno ir prokuroro bendradarbiavimą. Teisinėje literatūroje nemažai diskutuojama apie ikiteisminio tyrimo subjektų bendradarbiavimą, analizuojama bendradarbiavimo samprata, šių subjektų kompetencijos atskyrimo klausimai, tačiau ne tiek daug dėmesio skirta praktiniams tyrėjo ir prokuroro bendradarbiavimo klausimams nagrinėti. Atlikus empirinį tyrimą buvo atskleistas ikiteisminio tyrimo pareigūnų požiūris į prokurorų ir tyrėjų bendradarbiavimą ikiteisminiame tyrime. Tyrimo rezultatai parodė, jog dažnai ikiteisminio tyrimo pareigūnas ir prokuroras bendradarbiauja nepakankamai, formaliai, taikomos neefektyvios bendradarbiavimo formos. Viena dažniausių bendradarbiavimo formų – ikiteisminio tyrimo pareigūno formalus pranešimas apie ikiteisminio tyrimo eigą raštu. Beveik nebendraujama telefonu, prokuroras tiesiogiai nesusitinka su tyrėju aptarti bylos eigą. Tai daug efektyvesnės bendradarbiavimo formos. Tad akivaizdu, jog būtina didesnį dėmesį skirti bendradarbiavimo turiniui, formoms, spręsti klausimą dėl teisinio bendradarbiavimo įtvirtinimo. Straipsnyje autorė analizuoja ikiteisminio tyrimo subjektų bendradarbiavimo sampratą, nagrinėja ikiteisminio tyrimo pareigūnų požiūrį į prokuroro ir tyrėjo bendradarbiavimą ikiteisminiame tyrime bei pateikia siūlymus, kaip pagerinti minėtų subjektų bendradarbiavimą nusikalstamų veikų tyrimo procese: siūloma apibrėžti bendradarbiavimo principus, formas, turinį, reglamentuoti bendradarbiaujančių subjektų atsakomybę, bendradarbiavimo procese taikyti efektyvesnes bendradarbiavimo formas ir Baudžiamojo proceso kodekse įtvirtinti bendradarbiavimo institutą
Management and prevention of chronic obstructive pulmonary disease exacerbations: a state of the art review
No full textExacerbations of chronic obstructive pulmonary disease (COPD) are important events in the natural history of this prevalent and devastating condition. This review provides a concise, state of the art summary on prevention and management of exacerbations. Considerable new data underpins evidence in support of many preventative interventions, pharmacological and non-pharmacological, that are now available. Challenges remain in developing new approaches, and delivering those that already exist to the right patient at the right time. Management of an exacerbation remains stepwise according to clinical severity, but there is now additional focus on addressing comorbidities and taking the opportunity at acute events to optimise preventative strategies for the future. Ultimately, exacerbations are heterogeneous events in a heterogeneous disease, and an individualised approach is paramount
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