The new UK research governance: its impact on pharmacy undergraduate research projects

Implementation of the Department of Health Research Governance Framework (RGF) in the United Kingdom has major implications for the conduct of pharmacy practice undergraduate research projects. This paper draws upon a survey of local ethics research committees (LRECs) in the greater Birmingham area to identify the issues that arise from the RGF in relation to non-clinical practice research in community pharmacy. Although there is some evidence of minor differences between LRECs, the overwhelming finding is that projects will be subject to the full force of the RGF. The implications are discussed in relation to specific issues relating to non-clinical research, the professional aspirations for a research capable workforce, and the expertise within pharmacy to meet the current accreditation requirements for undergraduate projects.

The impact of leadership and quality climate on hospital performance

Objective. To explore the relationship between leadership effectiveness and health-care trust performance, taking into account external quality measures and the number of patient complaints; also, to examine the role of care quality climate as a mediator. Design. We developed scales for rating leadership effectiveness and care quality climate. We then drew upon UK national indices of health-care trust performance—Commission for Health Improvement star ratings, Clinical Governance Review ratings and the number of patient complaints per thousand. We conducted statistical analysis to examine any significant relationships between predictor and outcome variables. Setting. The study is based on 86 hospital trusts run by the National Health Service (NHS) in the UK. The data collection is part of an annual staff survey commissioned by the NHS to explore the quality of working life. Participants. A total of 17 949 employees were randomly surveyed (41% of the total sample). Results. Leadership effectiveness is associated with higher Clinical Governance Review ratings and Commission for Health Improvement star ratings for our sample (ß = 0.42, P < 0.05; ß = 0.37, P < 0.05, respectively), and lower patient complaints (ß = –0.57, P < 0.05). In addition, 98% of the relationship between leadership and patient complaints is explained by care quality climate. Conclusions. Results offer insight into how non-clinical leadership may foster performance outcomes for health-care organizations. A frequently neglected area—patient complaints—may be a valid measure to consider when assessing leadership and quality in a health-care context.

A demonstration of attentional bias, using a novel dual task paradigm, towards clinically salient material in recovering alcohol abuse patients?

Background. This study examined whether alcohol abuse patients are characterized either by enhanced schematic processing of alcohol related cues or by an attentional bias towards the processing of alcohol cues. Method. Abstinent alcohol abusers (N = 25) and non-clinical control participants (N = 24) performed a dual task paradigm in which they had to make an odd/even decision to a centrally presented number while performing a peripherally presented lexical decision task. Stimuli on the lexical decision task comprised alcohol words, neutral words and non-words. In addition, participants completed an incidental recall task for the words presented in the lexical decision task. Results. It was found that, in the presence of alcohol related words, the performance of patients on the odd/even decision task was poorer than in the presence of other stimului. In addition, patients displayed slower lexical decision times for alcohol related words. Both groups displayed better recall for alcohol words than for other stimuli. Conclusions. These results are interpreted as supporting neither model of drug cravings. Rather, it is proposed that, in the presence of alcohol stimuli, alcohol abuse patients display a breakdown in the ability to focus attention.

An investigation into the impact of safety features on the ergonomics of surgical scalpels

In the case of surgical scalpels, blade retraction and disposability have been incorporated into a number of commercial designs to address sharps injury and infection transmission issues. Despite these new designs, the traditional metal reusable scalpel is still extensively used and this paper attempts to determine whether the introduction of safety features has compromised the ergonomics and so potentially the take-up of the newer designs. Examples of scalpels have been analysed to determine the ergonomic impact of these design changes. Trials and questionnaires were carried out using both clinical and non-clinical user groups, with the trials making use of assessment of incision quality, cutting force, electromyography and video monitoring. The results showed that ergonomic performance was altered by the design changes and that while these could be for the worse, the introduction of safety features could act as a catalyst to encourage re-evaluation of the ergonomic demands of a highly traditional product.

Validation of the Paediatric food allergy quality of life questionnaire (PFA-QL)

Objective - The aim of the current study was to validate child (PFA-QL) and parent–proxy (PFA-QL-PF) versions of the scale in a specialist allergy clinic and in parents of children with food allergy. Methods - For the clinic sample, a generic QoL scale (PedsQL) and the PFA-QL were completed by 103 children (age 6–16 yrs) with peanut or tree nut allergy; test–retest reliability of the PFA-QL was tested in 50 stable patients. For the non-clinical sample, 756 parents of food allergic children completed the PFA-QL-PF, the Child Health Questionnaire (CHQ-PF50), Food Allergy Quality of Life Parental Burden Scale (FAQL-PB) and a Food Allergy Impact Measure. Results - The PFA-QL and PFA-QL-PF had good internal consistency (a's of 0.77–0.82), and there was moderate-to-good agreement between the generic- and disease-specific questionnaires. The PFA-QL was stable over time in the clinic sample, and in both samples, girls were reported to have poorer QoL than boys. Conclusions - The PFA-QL and PFA-QL-PF are reliable and valid scales for use in both clinical and non-clinical populations. Unlike other available tools, they were developed and validated in the UK and thus provide a culture-specific choice for research, clinical trials and clinical practice in the UK. Validation in other countries is now needed.

Priming moral self-ambivalence heightens deliberative behaviour in self-ambivalent individuals

Background: Recent work on cognitive-behavioural models of obsessive-compulsive disorder has focused on the roles played by various aspects of self-perception. In particular, moral self-ambivalence has been found to be associated with obsessive-compulsive phenomena. Aims: In this study we used an experimental task to investigate whether artificially priming moral self-ambivalence would increase participants' deliberation on ethical problems, an index that might be analogous to obsessive-compulsive behaviour. Method: Non-clinical participants completed two online tasks designed to prime either moral self-ambivalence, general uncertainty, or neither. All participants then completed a task requiring them to consider solutions to moral dilemmas. We recorded the time participants took to respond to the dilemmas and the length of their responses; we then combined these variables to create a measure of deliberation. Results: Priming moral self-ambivalence led to increases in deliberation, but this was only significant among those participants who scored highly on a baseline measure of moral self-ambivalence. Priming general uncertainty had no significant effect upon deliberation. Conclusions: The results suggest that moral self-ambivalence may play a role in the maintenance of obsessive-compulsive behaviour. We propose that individuals who are morally self-ambivalent might respond to situations in which this ambivalence is made salient by exhibiting behaviour with obsessive-compulsive characteristics. These findings have implications for the incorporation of ideas about self-concept into theories of obsessive-compulsive disorder.

Are dieting-related cognitive impairments a function of iron status?

The aim of the present study was to investigate whether the impairments in cognitive function observed in unsupported dieting are related to compromised Fe status. During a non-clinical intervention, overweight participants (age: 18-45 years, BMI: 25-30 kg/m2) either participated in a commercially available weight-loss regimen (n 14), dieted without support (n 17) or acted as a non-dieting control group (n 14) for a period of 8 weeks. Measurements of cognitive function and blood chemistry were taken at a pre-diet baseline, after 1 week and 8 weeks of dieting. After 1 week, unsupported dieters displayed impaired verbal memory, executive function and slower reaction speeds than the other two groups, this difference disappearing by the end of the study. There were no significant group-related changes in blood chemistry over the course of the study, although there were group-related changes in a number of self-reported food-related cognitions. In conclusion, impaired cognition among unsupported dieters is not due to compromised Fe status and is most likely to result from psychological variables. © 2012 The Authors.

The influence of eating psychopathology on autobiographical memory specificity and social problem-solving

The primary aim was to examine to influence of subclinical disordered eating on autobiographical memory specificity (AMS) and social problem solving (SPS). A further aim was to establish if AMS mediated the relationship between eating psychopathology and SPS. A non-clinical sample of 52 females completed the autobiographical memory test (AMT), where they were asked to retrieve specific memories of events from their past in response to cue words, and the means-end problem-solving task (MEPS), where they were asked to generate means of solving a series of social problems. Participants also completed the Eating Disorders Inventory (EDI) and Hospital Anxiety and Depression Scale. After controlling for mood, high scores on the EDI subscales, particularly Drive-for-Thinness, were associated with the retrieval of fewer specific and a greater proportion of categorical memories on the AMT and with the generation of fewer and less effective means on the MEPS. Memory specificity fully mediated the relationship between eating psychopathology and SPS. These findings have implications for individuals exhibiting high levels of disordered eating, as poor AMS and SPS are likely to impact negatively on their psychological wellbeing and everyday social functioning and could represent a risk factor for the development of clinically significant eating disorders.

Defining response to anti-VEGF therapies in neovascular AMD

The introduction of anti-vascular endothelial growth factor (anti-VEGF) has made significant impact on the reduction of the visual loss due to neovascular age-related macular degeneration (n-AMD). There are significant inter-individual differences in response to an anti-VEGF agent, made more complex by the availability of multiple anti-VEGF agents with different molecular configurations. The response to anti-VEGF therapy have been found to be dependent on a variety of factors including patient’s age, lesion characteristics, lesion duration, baseline visual acuity (VA) and the presence of particular genotype risk alleles. Furthermore, a proportion of eyes with n-AMD show a decline in acuity or morphology, despite therapy or require very frequent re-treatment. There is currently no consensus as to how to classify optimal response, or lack of it, with these therapies. There is, in particular, confusion over terms such as ‘responder status’ after treatment for n-AMD, ‘tachyphylaxis’ and ‘recalcitrant’ n-AMD. This document aims to provide a consensus on definition/categorisation of the response of n-AMD to anti-VEGF therapies and on the time points at which response to treatment should be determined. Primary response is best determined at 1 month following the last initiation dose, while maintained treatment (secondary) response is determined any time after the 4th visit. In a particular eye, secondary responses do not mirror and cannot be predicted from that in the primary phase. Morphological and functional responses to anti-VEGF treatments, do not necessarily correlate, and may be dissociated in an individual eye. Furthermore, there is a ceiling effect that can negate the currently used functional metrics such as >5 letters improvement when the baseline VA is good (ETDRS>70 letters). It is therefore important to use a combination of both the parameters in determining the response.The following are proposed definitions: optimal (good) response is defined as when there is resolution of fluid (intraretinal fluid; IRF, subretinal fluid; SRF and retinal thickening), and/or improvement of >5 letters, subject to the ceiling effect of good starting VA. Poor response is defined as <25% reduction from the baseline in the central retinal thickness (CRT), with persistent or new IRF, SRF or minimal or change in VA (that is, change in VA of 0+4 letters). Non-response is defined as an increase in fluid (IRF, SRF and CRT), or increasing haemorrhage compared with the baseline and/or loss of >5 letters compared with the baseline or best corrected vision subsequently. Poor or non-response to anti-VEGF may be due to clinical factors including suboptimal dosing than that required by a particular patient, increased dosing intervals, treatment initiation when disease is already at an advanced or chronic stage), cellular mechanisms, lesion type, genetic variation and potential tachyphylaxis); non-clinical factors including poor access to clinics or delayed appointments may also result in poor treatment outcomes. In eyes classified as good responders, treatment should be continued with the same agent when disease activity is present or reactivation occurs following temporary dose holding. In eyes that show partial response, treatment may be continued, although re-evaluation with further imaging may be required to exclude confounding factors. Where there is persistent, unchanging accumulated fluid following three consecutive injections at monthly intervals, treatment may be withheld temporarily, but recommenced with the same or alternative anti-VEGF if the fluid subsequently increases (lesion considered active). Poor or non-response to anti-VEGF treatments requires re-evaluation of diagnosis and if necessary switch to alternative therapies including other anti-VEGF agents and/or with photodynamic therapy (PDT). Idiopathic polypoidal choroidopathy may require treatment with PDT monotherapy or combination with anti-VEGF. A committee comprised of retinal specialists with experience of managing patients with n-AMD similar to that which developed the Royal College of Ophthalmologists Guidelines to Ranibizumab was assembled. Individual aspects of the guidelines were proposed by the committee lead (WMA) based on relevant reference to published evidence base following a search of Medline and circulated to all committee members for discussion before approval or modification. Each draft was modified according to feedback from committee members until unanimous approval was obtained in the final draft. A system for categorising the range of responsiveness of n-AMD lesions to anti-VEGF therapy is proposed. The proposal is based primarily on morphological criteria but functional criteria have been included. Recommendations have been made on when to consider discontinuation of therapy either because of success or futility. These guidelines should help clinical decision-making and may prevent over and/or undertreatment with anti-VEGF therapy.

A New Class of Processes for Formalizing and Generalizing Individual-Based Models: The Semi-Semi-Markov Processes

2000 Mathematics Subject Classification: 60K15, 60K20, 60G20,60J75, 60J80, 60J85, 60-08, 90B15.

Intentional forgetting in dysphoria:investigating the inhibitory effects of thought substitution using independent cues

Background Individuals with clinical and subclinical depression (dysphoria) exhibit problems intentionally forgetting unwanted memories on the think/no-think (TNT) paradigm (Anderson & Green, 2001). However, providing substitute words to think about instead of the to-be-forgotten targets can improve forgetting in depressed patients. Objectives To determine if thought substitution can enhance forgetting in dysphoric participants and to examine the potential mechanisms (blocking or inhibition) that might underpin successful forgetting. Methods Thirty-six dysphoric and 36 non-dysphoric participants learned neutral word-pairs and then practiced responding with the targets to some cues (think trials) and suppressing responses to others (no think trials). Half the participants were provided with substitute words to recall instead of the original targets (aided suppression) and half were simply told to avoid thinking about the targets (unaided suppression). Finally, participants completed two recall tests for the targets; one cued with the original probes and one with independent probes. Results Regardless of suppression condition (aided or unaided), dysphoric participants exhibited impaired forgetting, relative to their non-dysphoric counterparts, but only when cued with the original probes. Furthermore, higher depression scores were associated with poorer forgetting. In the aided condition, successful forgetting was observed on both the original and independent probe tasks, which supports the inhibitory account of thought substitution. Limitations Non-clinical status of the dysphoric participants was not confirmed using a validated measure. Conclusions Findings do not support the utility of thought substitution as a method of improving the forgetting in depressed participants, but do support the inhibition account of thought substitution.

The effect of cross -age tutoring routines on the tutor's perception of self as reader

Perception of self as a non-reader has been identified as one of the factors why poor readers disengage from the reading process (Strang, 1967; Rosow, 1992), thus impeding progress. Perception and informational processes influence judgments of personal efficacy (Bandura, 1997). The student's sense of reading efficacy that influence effort expenditure and ultimately achievement, is often overlooked (Athey, 1985; Pajares, 1996). Academic routines within educational programs are implemented without adequate information on whether routines promote or impede efficacy growth. Cross-age tutoring, a process known to improve participants' academic achievement, motivation, and provide opportunities for authentic reading practice, has been successfully incorporated into reading instruction designs (Allen, 1976; Cohen, Kulik & Kulik, 1982; Labbo & Teale, 1990; Riessman, 1993). This study investigated the impact teacher-designed routines within a cross-age tutoring model, have on the tutor's sense of reading self-efficacy. ^ The Reader Self-Perception Scale (Henk & Melnick, 1992) was administered, pre- and post-treatment, to 118 fifth grade students. Preceding the initial survey administration intact classes were randomly assigned to 1 of 3 commonly utilized cross-age tutoring routines or designated as the non-treatment population. The data derived from the Reader Self-Perception Scale was analyzed using an analysis of covariance (ANCOVA). Results indicated that participation as a cross-age tutor does not significantly increase the tutor's perception of self as reader in 1 or more of the 4 modes of information influencing self-efficacy as compared to the non-treatment group. ^ The results of this study suggests that although a weekly tutoring session that delivers educationally credible routines impacts achievement and motivation, efficacy effect was not evident. Possible explanation and recommendations for future studies are proposed. ^

Ansiedade social e cooperação em contexto de hierarquia social

The Ultimatum Game is a methodology of the Game Theory that intends to investigate the individuals cooperative behavior in situations of resources division. Studies have shown that half of the subjects don’t accept unfair division of resources, and prefer to bear a momentary cost to revenge the deceivers. However, people who have assertiveness impairment, such as social phobic individuals, could have some difficulties to reject unfair offer division resource, especially in situations that cause over anxiety, like being in the presence of an individual considered to be in a high hierarchical level. A negative perception about his own worth can also make the person thinks that he does not deserve a fair division. These individuals also have a strong desire to convey a positive impression to the others, which could cause them to be more generous in a resource division. The aim of this study was to verify, through the Ultimatum Game, if social anxiety individuals would accept more high confederate’s unfair offers that low confederate’s unfair offers; and if they would be more generous in goods division, in the same game, when compared to individuals without social anxiety. Ninety-five (95) college students participated in this study answering the Social Phobia Inventory, the Factorial Scale of Extroversion, socio-demographic questionnaire, situational anxiety scale and, finally, the Ultimatum Game in four rounds (1st and 3rd – confederate representing high or low ranking using an unfair proposal; 2nd – confederate without social status using fair proposal; 4th – subject’s research proposes the offer). The results showed a significant negative correlation between social anxiety and haughtiness, and social anxiety and assertiveness, and a significant positive correlation between social anxiety and situational anxiety. There was no significant difference in situational anxiety due to the status for anxious individuals. Also we found no significant difference in the amount of donated goods, showing that generous behavior does not differ between groups. Finally, the social status did not influence the decision in response to the game for anxious individuals. These results corroborate to other studies that show the relationship between social anxiety and assertiveness, and social anxiety and negative self-perception capability and value (low haughtiness). As show the results of situational anxiety scale, the high status stimulus was not perceived as threatening to the individual, which may have affected his answer in the game. The results for the Ultimatum Game follow the same direction as the acceptance rate for unfair proposals (approximately 50%) in studies with non-clinical sample.

Ansiedade social e cooperação em contexto de hierarquia social

The Ultimatum Game is a methodology of the Game Theory that intends to investigate the individuals cooperative behavior in situations of resources division. Studies have shown that half of the subjects don’t accept unfair division of resources, and prefer to bear a momentary cost to revenge the deceivers. However, people who have assertiveness impairment, such as social phobic individuals, could have some difficulties to reject unfair offer division resource, especially in situations that cause over anxiety, like being in the presence of an individual considered to be in a high hierarchical level. A negative perception about his own worth can also make the person thinks that he does not deserve a fair division. These individuals also have a strong desire to convey a positive impression to the others, which could cause them to be more generous in a resource division. The aim of this study was to verify, through the Ultimatum Game, if social anxiety individuals would accept more high confederate’s unfair offers that low confederate’s unfair offers; and if they would be more generous in goods division, in the same game, when compared to individuals without social anxiety. Ninety-five (95) college students participated in this study answering the Social Phobia Inventory, the Factorial Scale of Extroversion, socio-demographic questionnaire, situational anxiety scale and, finally, the Ultimatum Game in four rounds (1st and 3rd – confederate representing high or low ranking using an unfair proposal; 2nd – confederate without social status using fair proposal; 4th – subject’s research proposes the offer). The results showed a significant negative correlation between social anxiety and haughtiness, and social anxiety and assertiveness, and a significant positive correlation between social anxiety and situational anxiety. There was no significant difference in situational anxiety due to the status for anxious individuals. Also we found no significant difference in the amount of donated goods, showing that generous behavior does not differ between groups. Finally, the social status did not influence the decision in response to the game for anxious individuals. These results corroborate to other studies that show the relationship between social anxiety and assertiveness, and social anxiety and negative self-perception capability and value (low haughtiness). As show the results of situational anxiety scale, the high status stimulus was not perceived as threatening to the individual, which may have affected his answer in the game. The results for the Ultimatum Game follow the same direction as the acceptance rate for unfair proposals (approximately 50%) in studies with non-clinical sample.

Remédiation cognitive portant sur les aspects fluide et cristallisé de l’intelligence auprès d'adolescents présentant un fonctionnement intellectuel limite : approche par le jeu.

L’objectif principal de cette thèse était de créer, d’implanter et d’évaluer l’efficacité d’un programme de remédiation cognitive, intervenant de façon comparable sur les aspects fluide (Gf) et cristallisé (Gc) de l’intelligence, au sein d’une population d’intérêt clinique, les adolescents présentant un fonctionnement intellectuel limite (FIL). Compte tenu de la forte prévalence de ce trouble, le programme de remédiation GAME (Gains et Apprentissages Multiples pour Enfant) s’est développé autour de jeux disponibles dans le commerce afin de faciliter l’accès et l’implantation de ce programme dans divers milieux. Le premier article de cette thèse, réalisé sous forme de revue systématique de la littérature, avait pour objectif de faire le point sur les études publiées utilisant le jeu comme outil de remédiation cognitive dans la population pédiatrique. L’efficacité, ainsi que la qualité du paradigme utilisé ont été évaluées, et des recommandations sur les aspects méthodologiques à respecter lors de ce type d’étude ont été proposées. Cet article a permis une meilleure compréhension des écueils à éviter et des points forts méthodologiques à intégrer lors de la création du programme de remédiation GAME. Certaines mises en garde méthodologiques relevées dans cet article ont permis d’améliorer la qualité du programme de remédiation cognitive développé dans ce projet de thèse. Compte tenu du peu d’études présentes dans la littérature scientifique concernant la population présentant un FIL (70population à laquelle s’adressait le programme GAME, notamment concernant son fonctionnement cognitif, adaptatif, comportemental et psychiatrique. La deuxième étude de cette thèse a donc permis de préciser le profil de cette population de manière empirique. Dans le domaine cognitif, une force a été mise en évidence au niveau langagier pour le vocabulaire réceptif et la fluence verbale. De plus, certains aspects des capacités attentionnelles et de la mémoire de travail semblaient être bien compensés, possiblement via l’effet de psychostimulants. Étonnamment, le fonctionnement adaptatif n’était pas directement relié au niveau intellectuel global et était hétérogène, suggérant l’importance d’évaluer ce domaine pour rendre compte du niveau de fonctionnement des adolescents présentant un FIL dans la vie quotidienne. D’un point de vue comportemental et psychiatrique, les adolescents avec un FIL avaient plus de manifestations internalisées et externalisées atteignant un seuil cliniquement significatif que leurs pairs. Ces manifestations comportementales expliquent d’ailleurs une part importante du niveau de stress parental dans cette population. Ces résultats sont importants à considérer lors de l’orientation académique, clinique et familiale dans la prise en charge des adolescents présentant un FIL, et soulignent l’importance de proposer une évaluation neuropsychologique approfondie. Enfin, la partie centrale de cette thèse consistait à créer un programme de remédiation cognitive portant sur les aspects fluide et cristallisé de l’intelligence, champs d’intervention qui a été négligé compte tenu de la stabilité longtemps postulée de ces processus. Ce programme de remédiation, intitulé GAME, s’adressait aux adolescents présentant un FIL pur ou partiel (soit les deux indices de raisonnement étaient dans la zone limite, soit un seul des deux), et présentait deux versants, GAME-c (portant sur l’intelligence cristallisée) et GAME-f (portant sur l’intelligence fluide). Cette intervention durait seize heures réparties sur huit semaines. Les résultats indiquent que les adolescents ayant suivi GAME-f ont amélioré leur raisonnement fluide; alors que les adolescents ayant suivi GAME-c ont amélioré à la fois leur raisonnement cristallisé et fluide. Cette étude contribue à remettre en question la stabilité des processus intellectuels. C’est par contre la première fois que des améliorations de l’intelligence sont constatées dans une population d’intérêt clinique par le biais d’un entraînement direct. Enfin, les variables cognitives, adaptatives, comportementales et psychiatriques susceptibles d’influencer la qualité de l’amélioration pour chacun des programmes GAME ont fait l’objet d’analyses supplémentaires dans un dernier chapitre et permettent de conclure à la possibilité d’adapter le programme GAME à d’autres populations (ex: déficience intellectuelle). Cette thèse a donc permis de souligner la pertinence d’utiliser les jeux comme outil de remédiation cognitive de part leur versatilité dans leur utilisation, leur facilité d’accès et leur faible coût. Elle met également en avant la nécessité de développer une meilleure compréhension de la population présentant un fonctionnement intellectuel limite et d’effectuer des évaluations neuropsychologiques exhaustives auprès de cette population (cognitif, adaptatif, comportemental et psychiatrique). Enfin, elle souligne la possibilité d’améliorer par remédiation directe les intelligences fluide et cristallisée auprès d’individus avec une intelligence subnormale et suggère qu’il pourrait en être de même pour des populations présentant des déficits cognitifs, comme la déficience intellectuelle légère. Les avenues futures de recherche et les retombées cliniques de ce travail sont discutées, en lien avec les différents résultats trouvés dans ces études.