Randomized controlled trials (RCTs) are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1) clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2) both significant and nonsignificant results should be objectively reported and published, 3) structured study design and performance as indicated in the Consolidated Standards of Reporting Trials statement should be employed as well as registration in a public trial database, 4) potential conflicts of interest and funding sources should be disclaimed in study report or publication, and 5) in the comparison of experimental treatment with standard care, preplanned interim analyses during an ongoing RCT can aid in maintaining clinical equipoise by assessing benefit, harm, or futility, thus allowing decision on continuation or termination of the trial.

Fingertip amputation injuries are common in all ages. Conservatively treated fingertips can regenerate skin and soft tissues to form a functionally and cosmetically excellent new fingertip. Little is known about this ability that, in humans, is confined to the fingertips. Even less is known about the role of the bacteria that regularly colonize these wounds without negative impact on regeneration and healing. As an alternative to surgery, self-adhesive film dressings are commonly used to establish a wet chamber around the injury. These dressings leak malodorous wound fluid eventually until the wound is dry. Having that into consideration, we have therefore developed a silicone finger cap that forms a mechanically protected, wet chamber around the injury for optimal regeneration conditions. It contains a puncturable reservoir for excess wound fluid, which can be thus routinely analyzed for diagnostic and research purposes. This study protocol explains the first randomized controlled trial (RCT) on the semiocclusive treatment of fingertip amputations in both children and adults comparing traditional film dressings with the novel silicone finger cap. Being the first RCT using 2 medical devices not yet certified for this indication, it will gather valuable information for the understanding of fingertip regeneration and the design of future definitive studies.

Baserat på Self-Determination Theory (SDT) och en randomiserad kontrollstudiedesign undersöktes effekten av autonomistödjande textmeddelanden i jämförelse med neutrala meddelanden eller inga meddelanden på deltagarnas behovstillfredsställelse, motivation, och aktivitetsnivå. Digital kvantitativ datainsamling användes där webbenkäterna skickades ut tre gånger till deltagarna, innan, under samt efter intervention. Totalt 107 frivilliga män och kvinnor svarade vid baslinjemätningen och delades sedan in i tre olika grupper, inaktiv kontrollgrupp (n = 45), aktiv kontrollgrupp (n = 29) samt interventionsgrupp (n = 33). Interventionen ägde rum i samband med en stegtävling. Textmeddelandena skickades ut till deltagarna i aktiva kontrollgruppen och interventionsgruppen två gånger varje vecka under åtta veckor, via en digital plattform. Det förelåg inga signifikanta skillnader mellan grupperna vid baslinjemätningen. En tvåvägs-ANOVA (repeated measure) visade att interventionen hade en signifikant effekt på upplevelsen av tillhörighet under interventionen. Dock förelåg inga andra signifikanta interventionseffekter. Det sammanlagda resultatet antyder således att den digitala interventionen, det vill säga att tillhandahålla deltagarna med autonomistödjande textmeddelanden, inte har någon bestående effekt på deltagarnas behovstillfredsställelse, motivation eller aktivitetsnivå. / Based on Self-Determination Theory (SDT) and a randomized controlled trial design, the effect of autonomy-supportive text messages was examined in comparison with neutral messages or no messages regarding the participants basic psychological needs, motivation and activity level. Digital quantitative data collection was used, and the web surveys were sent out three times to participants, pre, during and post intervention. A total of 107 male and female volunteers responded to the baseline measurement and were then divided into three different groups, inactive control group (n = 45), active control group (n = 29) and intervention group (n = 33). The intervention took place in relation to a step contest. Text messages were sent to the participant’s in the active control group and intervention group twice a week for a total of eight weeks, via a digital platform. There were no significant differences between the groups in the baseline measurement. A two-way ANOVA (repeated measure) showed that the intervention had a significant effect on the experience of relatedness during the intervention. However, there were no other significant intervention effects. The results suggest that the digital intervention, to provide participants with autonomy supportive text messages, does not have a lasting effect on need satisfaction, motivation or activity level.

Objectives: To study the treatment practice of chronic tennis elbow (TE) among general practitioners (GPs) and physiotherapists (PTs), the effects of a simple, graded home exercise regime versus expectation, the effects of eccentric versus concentric exercise, and the involvement of the substance P – NK1 receptor system in the peripheral, painful tissue of chronic TE patients by positron emission tomography (PET). Materials and methods: A postal survey regarding therapeutic methods used in patients with chronic TE was sent to 129 GPs and 77 PTs, 81 subjects with chronic TE were randomly and blindly assigned to either an exercise group or a wait list group, 120 subjects were randomly assigned to either eccentric or concentric exercise and ten subjects were examined by PET and the NK1 specific radioligand [11C]GR205171. Results: High proportions of GPs and PTs used ergonomic counselling and stretching in the treatment of chronic TE. The majority of GPs prescribed passive anti-inflammatory measures such as sick leave and anti-inflammatory medication. Many PTs prescribed dynamic, particularly eccentric, exercise. Graded dynamic exercise according to a simple low-cost protocol, has better effect on pain than a wait-and-see attitude. Adjusted for outcome affecting variables, eccentric graded exercise has quicker effect than concentric graded exercise. During PET scan with the NK1 specific radioligand [11C]GR205171, voxel volume and signal intensity of this volume was significantly higher in the affected than the unaffected arm in subjects with unilateral chronic TE. Conclusions: GPs and PTs used many treatments to a similar extent but differed regarding the use of exercise. Chronic TE responds favourably to graded dynamic exercise aimed specifically at the painful tissue. The exercise should stress the eccentric work phase. The substance P – NK1 receptor system seems to play a part in the peripheral, painful tissue of a chronic, soft tissue pain condition such as chronic TE. / Epi-X

Submitted by Felipe Augusto Ferreira de Almeida null (felipeafalmeida@gmail.com) on 2016-12-20T16:56:04Z No. of bitstreams: 1 DISSERTACAO_FELIPE_FINAL.pdf: 3666708 bytes, checksum: 18899b06cbe9a7091fd3f037b0656174 (MD5) / Approved for entry into archive by Felipe Augusto Arakaki (arakaki@reitoria.unesp.br) on 2016-12-22T10:53:09Z (GMT) No. of bitstreams: 1 almeira_faf_me_bauru.pdf: 3666708 bytes, checksum: 18899b06cbe9a7091fd3f037b0656174 (MD5) / Made available in DSpace on 2016-12-22T10:53:09Z (GMT). No. of bitstreams: 1 almeira_faf_me_bauru.pdf: 3666708 bytes, checksum: 18899b06cbe9a7091fd3f037b0656174 (MD5) Previous issue date: 2016-11-03 / Instituto Federal de Educação, Ciência e Tecnologia de São Paulo (IFSP) / Este trabalho aborda o emprego do Compensador Estático de Reativos (SVC) em redes de baixa tensão com geração distribuída de energia, tendo como objetivo a compensação de tensão e de fator de potência. Os principais distúrbios de qualidade de energia elétrica em baixa tensão, bem como as normas e os limites operacionais para os principais indicadores foram revisados, visando confrontação com as situações resultantes da integração do SVC no sistema elétrico. O SVC possui operação estabelecida como carga reativa controlável em sistemas de transmissão de energia, fazendo parte dos condicionadores da tecnologia FACTS (Flexible AC Transmission Systems). A exploração desta tecnologia em outro nível de tensão é o objetivo deste trabalho. As análises foram realizadas através de simulações computacionais, desenvolvidas no ambiente MATLAB, contemplando o desenvolvimento de modelos relacionados com aplicações de RCT (Reator Controlado a Tiristor), FC (Capacitor Fixo), do CCT (Capacitor Chaveado a Tiristor) e de um sistema de geração distribuída de energia elétrica trifásico em uma rede de baixa tensão a quatro fios. A metodologia para o dimensionamento dos elementos passivos dos condicionadores é apresentada, bem como a análise dos valores de potência reativa, fator de potência, distorções harmônicas e a avaliação da necessidade de utilização ou não de filtros passivos. A teoria da potência conservativa (TPC) é a metodologia utilizada para definição das grandezas elétricas e fatores de conformidade. Por fim, as características operacionais de um SVC aplicado a uma rede de baixa tensão a quatro fios são exploradas através dos resultados de simulação, com o objetivo de demonstrar a manutenção de suas características operacionais estabelecidas, no nível de baixa tensão, e apontar aspectos diferenciados quanto à regulação de fator de potência e da forma de tensão providos pelo SVC, para servir como informação de confronto frente a outras tecnologias comumente utilizadas neste nível de tensão. / This paper discusses the use of Static Var Compensator (SVC) on low voltage grids with distributed generation with the aim of voltage and power factor compensation. The main electrical power quality disturbances at low voltage as well as the rules and operational limits for the main indicators were reviewed aiming to confront the situations resulting from SVC integration in the electrical system. SVC has established operation as controllable reactive load in power transmission systems, being part of FACTS (Flexible AC Transmission Systems) technology conditioners. The application of this technology in another level of tension is the objective of this work. The analyzes were carried out through computer simulations developed in the MATLAB environment, including the development of models related to RCT (Thyristor Controlled Reactor), FC (Fixed Capacitor), CCT (Thyristor Switching Capacitor) and a threephase electric power distributed generation system in a four-wire low voltage grid. The methodology for the dimensioning of the passive elements of the conditioners is presented, as well as the analysis of the values of reactive power, power factor, harmonic distortions and the evaluation of the need to use passive filters. The conservative power theory (CPT) is the methodology used to define the electrical magnitudes and compliance factors. Finally, the operational characteristics of a SVC applied to a low-voltage four-wire network are exploited through the simulation results, in order to demonstrate the maintenance of its established operational characteristics at the low voltage level and to point out different aspects as well as the power factor regulation and voltage form provided by the SVC, to serve as confronting information.

Il presente elaborato ha come tema il ruolo dello psicologo clinico nella riabilitazione cardiologica, con una particolare attenzione alle sfide poste nel sostenere e facilitare il cambiamento dello stile di vita del paziente affetto da cardiopatia ischemica. La tesi si articola in tre sezioni, ognuna delle quali comprende un’introduzione teorica, con spunti sia di natura clinica che riferimenti al contesto della riabilitazione, e un contributo empirico che intende fornire una prospettiva innovativa al campo di riferimento. Il primo capitolo si apre con una breve descrizione della cardiopatia ischemica e dei fenomeni ad essa clinicamente legati. Queste informazioni introduttive si riveleranno preziose nello svolgersi dei capitoli successivi, in quanto consentono di approfondire il contesto della riabilitazione cardiologica, i suoi principali obiettivi e il razionale alla base dell'intervento clinico proposto. A questo proposito, verrà sottolineata la centralità dell’esercizio fisico come outcome funzionale della riabilitazione. In linea con questo affondo teorico, il primo contributo empirico è volto a indagare la relazione tra ridotta capacità di esercizio e sintomatologia ansiosa e depressiva, e a valutare la direzione di questa associazione attraverso un Cross-Lagged Panel Design che ha incluso 212 pazienti afferenti all’Unità di Riabilitazione Cardiovascolare dell’Ospedale S. Luca di Milano. I risultati sono discussi alla luce del ruolo che lo psicologo può svolgere per massimizzare il beneficio che il paziente può ottenere dalla riabilitazione, anche nei termini di capacità d’esercizio. Questo tema, accennato nella discussione del primo studio, viene ampliato nel secondo capitolo. Il secondo capitolo introduce infatti il modello dell’Acceptance and Commitment Therapy (ACT), riferimento teorico che costituisce l’ossatura dell’intervento presentato nella terza parte dell’elaborato. In particolare viene approfondito il ruolo della flessibilità psicologica, che rappresenta il cuore clinico del modello ACT, in quanto meccanismo primario di azione terapeutica. Per quanto esistano diversi strumenti per misurare questo costrutto, nessuno di essi è stato pensato e validato per il contesto cardiovascolare. La sezione empirica del secondo capitolo si riferisce allo sviluppo di un nuovo questionario per la misurazione della flessibilità psicologica adatto al contesto in esame - il CVD-AAQ, ovvero CardioVascular Disease Acceptance and Action Questionnaire - di cui vengono valutate le proprietà psicometriche. Lo studio si è avvalso di un secondo campione di 275 pazienti, arruolati nella medesima Unità Operativa. Il CVD-AAQ viene proposto e descritto in quanto misura di outcome dello studio presentato nella terza e ultima parte dell’elaborato. 8 Il terzo capitolo presenta lo studio ACTonHEART, un trial clinico randomizzato finalizzato a valutare l’efficacia e la fattibilità di un protocollo di intervento basato sull’ACT, cui scopo è migliorare il benessere e sostenere il cambiamento dello stile di vita dei pazienti ischemici in riabilitazione, aumentandone la flessibilità psicologica. Novantadue pazienti sono stati arruolati e allocati al gruppo sperimentale (N= 59) e di controllo (N= 33), seguendo uno schema di randomizzazione sbilanciata 2:1. Il gruppo di controllo ha svolto la sola riabilitazione, quello sperimentale in aggiunta ha partecipato all’intervento di gruppo ACTonHEART, il cui manuale è presentato integralmente in forma manualizzata. Il protocollo ha una durata di sei ore, suddivise in tre sedute, ognuna delle quali è incentrata su un principio clinico dell’ACT e affronta un aspetto diverso del cambiamento dello stile di vita richiesto al paziente ischemico in un’ottica di prevenzione secondaria. Gli outcome dell’ACTonHEART sono i seguenti: Body Mass Index, flessibilità psicologica e benessere. Ognuno di essi è stato misurato in tre occasioni: prima della riabilitazione (t0), al suo termine (t1) e in un follow-up a sei mesi (t2). Considerata la presenza di tre misurazioni e il fatto che solo i pazienti assegnati al gruppo sperimentale hanno partecipato a un trattamento di gruppo, da un punto di vista metodologico l’ACTonHEART si configura come un Partially Nested Design a tre livelli, un disegno di ricerca la cui struttura verrà brevemente descritta in una sezione dedicata. Per valutare l’efficacia del trattamento è stata infine svolta un’analisi multilivello, i cui risultati sono presentati e discussi nella sezione finale dell’elaborato. / The thematic core of the present paper consists in the role of clinical psychology in cardiac rehabilitation, with a specific focus on the challenges faced when supporting the changes in lifestyle required to patients suffering from ischemic heart disease. This thesis is divided into three broad sections. Every section includes a theoretical introduction, describing both clinical and rehabilitation state-of-the art practices and research results, and an empirical contribution aiming to provide an innovative perspective on the topics considered. The first chapter includes a brief description of ischemic heart disease and its clinically related phenomena. This introductory information will prove valuable in the subsequent chapters, as it deepens the context of cardiovascular rehabilitation, describing its main goals and the rationale behind its mode of intervention, as well as the centrality of exercise capacity as functional outcome. Starting from this theoretical background, the first empirical contribution aims at investigating the relationship between reduced exercise capacity and symptoms of anxiety and depression. The direction of this association will be evaluated through a Cross-Lagged Panel Design that included 212 patients recruited in the Cardiovascular Rehabilitation Unit of S. Luca Hospital in Milan. Results are discussed in light of the role the psychologist plays in order to maximize the impact the rehabilitation has on the patient, even in terms of exercise capacity. This theme, introduced in the discussion of the first study, is further explored in the second chapter. The second chapter introduces Acceptance and Commitment Therapy (ACT), the theoretical framework of ACTonHEART, which is the intervention presented in the third part of the thesis. In particular, psychological flexibility will be discussed as the primary mechanism of therapeutic action proposed by the ACT model. While there are several tools to measure this construct, none of them have been validated for the cardiovascular context. The empirical section of the second chapter presents a disease-specific new questionnaire for measuring the psychological flexibility, the Cardiovascular Disease Acceptance and Action Questionnaire (CVD-AAQ), whose psychometric properties are evaluated. The validation study examined a second sample of 275 patients enrolled in the same hospital. The CVD-AAQ will be used as a measure of outcome for the intervention presented in the third and last part of the elaborate. The third chapter presents the ACTonHEART study, a RCT aimed at evaluating the effectiveness and feasibility of an ACT-based intervention protocol, whose purpose is to improve well-being and support the change in lifestyle of ischemic patients, through an increase in psychological flexibility. 10 Ninety-two patients were enrolled and randomized, following an unbalanced randomization ratio of 2:1, to the experimental group (N= 59) and the control group (N= 33). The control group was administered Treatment-as-Usual (TAU), while experimental subjects participated in the ACTonHEART group intervention in addition to the cardiac rehabilitation process. In this section the ACTonHEART protocol will be entirely presented in its manualized form. The ACTonHEART protocol consists in three sessions for a total of six hours. Each session focuses on an ACT clinical principle and addresses a different aspect of the lifestyle changes asked to the ischemic patient for secondary prevention. The outcomes considered for the ACTonHEART are the following: Body Mass Index, Psychological Flexibility and Well-Being. Participants were assessed at baseline (t0), at the end of the rehabilitation period (t1), and at a six-month follow-up (t2). The ACTonHEART is a Partially nested Design with three levels, a research methodology whose structure will be briefly outlined in this section. An appropriate multilevel analysis was carried out to evaluate the effectiveness of the intervention, whose results are presented and discussed in the final section of the thesis.

No description available.

Impact evaluations in development interventions has been growing in recent years. The increasing demand for evidence-based outcomes has led to a debate of what methodology is best to evaluate the impact of development interventions. Accordingly, Randomised Controlled Trial (RCT) has been labeled as a gold standard for impact evaluations. The RCT method functions in a unique way, as it removes the selection bias and ensure high validity of a study. The aim of this research study is to critically assess the RCT as an alternative approach for impact assessment in relation to post-conflict countries; whether this claim holds in a conflict-affected environment or that the context-specific factors of post-conflict countries challenge the implementation of an RCT. This study implements mixed method approach by using simple descriptive statistics and semi-structured interview to answer the research questions. The findings of this study indicate that context-specific factors of post-conflict environments pose challenges on the implementation of an RCT.  As a result, these challenges threaten the quality of the RCT method which lies in reliability, internal validity and external validity. The findings also indicate that feasibility of RCT which lies in ethics, logistics and security, cannot be addressed individually, as the feasibility has a direct impact on the quality of the RCT method.

<p><strong>Background </strong>External cephalic version (ECV) is an effective intervention to reduce breech presentation and the corresponding Caesarean section (CS) rate. The Early ECV (EECV) trials were international multicentre randomized controlled trials that compared the timing of ECV (early or delayed) on obstetric and neonatal outcomes. In consideration of current recommendations that multicentre trials should account for centre effects in their analysis, a secondary analysis of the EECV trials was undertaken.</p> <p><strong>Purpose</strong> To analyse the EECV Trial data using statistical methods that account for centre effect and compare the results to standard analysis.<strong></strong></p> <p><strong>Methods </strong>Fisher’s exact test was used to provide overall results unadjusted for centre effects. The outcomes of interest were CS, preterm birth, and non-cephalic presentation at birth.</p> <p>Seven statistical models that accounted for centre effects were applied to the data: i) Mantel-Haenzsel test, ii) fixed effects regression, iii) fixed effects regression with a treatment-by-centre interaction term (weighted and iv) un-weighted by centre size), v) random intercept model, vi) random intercept and random slope model, and vii) generalized estimating equations.</p> <p><strong>Results </strong>Accounting for centre effects showed strengthened statistical associations with point estimates moving away from the null value.</p> <p><strong>Conclusion </strong>Effect estimates and confidence intervals changed for the three selected outcomes after accounting for centre effects, but the overall conclusions of the trial did not change. For this application, the Mantel-Haenzsel test and the random effects regressions performed the best. This study provides empirical evidence to support recommendations that multicentre trials account for centre in both design and analysis.</p> / Master of Health Sciences (MSc)

Background: Inflammatory Bowel Disease (IBD) is a group of chronic gastrointestinal diseases with a relapsing nature. The two main types are Crohn’s disease (CD) and ulcerative colitis (UC). Both CD and UC patients experience very similar and distressing symptoms: acute abdominal pain, vomiting, malnutrition, fever, fatigue, diarrhoea and rectal bleeding. These symptoms are disabling and have a severe impact on physical and psychosocial wellbeing. Around 30% of patients suffer from moderate to severe psychological distress and have difficulties coping with the illness even in remission. However, it appears that mental health is overlooked by clinicians who often focus on physical gastrointestinal symptoms only. Mindfulness-Based Cognitive Therapy (MBCT) is evidence based, group psychological intervention that has been successful in reducing depression and anxiety scores in patients with depression while improving overall quality of life. However, MBCT has never been tested in the IBD population before. PhD question: Can MBCT be used as an adjunct therapy to IBD symptom management, for improving IBD patients' general well-being and quality of life? Aims and objectives: The overall aim of the thesis was to develop and collate the evidence for a definitive randomised controlled trial (RCT) testing the effectiveness of MBCT for patients with inflammatory bowel disease (IBD). The thesis brings together six publications. The six publications were integrated into four objectives that collectively contributed in answering the overall PhD question. Results: The findings from the first three publications highlighted the disease-related concerns and psychological needs for patients with IBD. The findings from the last three publications highlighted how feasible it is to use MBCT in IBD and emphasised the IBD patients’ perspectives about MBCT. Conclusion: The thesis concluded that a definitive RCT of MBCT for IBD patients is both feasible and acceptable.