Tesi: "Randomised clinical trial (RCT)"

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Anjara, Sabrina Gabrielle. "A study of two models of primary mental health care provisions in Yogyakarta, Indonesia". Thesis, University of Cambridge, 2019. https://www.repository.cam.ac.uk/handle/1810/289729.

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Background The World Health Organization (WHO) defines health as a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity. Despite its importance, mental health provisions are often limited. In 2015, Indonesia had only 773 psychiatrists for 250 million residents. This shortage of specialist mental health professionals is shared by most Low- and Middle-Income Countries (LMICs) and is reflected in the Treatment Gaps in this region indicating the very small proportion of people who receive adequate mental health care for their needs. While the median worldwide Treatment Gap for psychosis is 32.2% (Kohn et al., 2004), in Indonesia it is more than 90%. Experts suggested integrating mental health care into primary care, to help bridge this gap (Mendenhall et al., 2014). The systematic introduction of the World Health Organization Mental Health Gap Action Programme into primary care clinics across Indonesia and the presence of a 15-year-old co-location of Clinical Psychologists in Yogyakarta province's primary care clinics presented an opportunity to assess the clinical and cost-effectiveness of both frameworks. Methods This research ("the trial") set out to develop an approach, and then implement it, to compare the adapted WHO mhGAP framework with the existing specialist framework within primary mental health services in Yogyakarta, Indonesia, through a pragmatic, two-arm cluster randomised controlled non-inferiority trial. This design enabled an examination of patients derived from whole populations in a 'real world' setting. The trial involved two phases: a pilot study in June 2016 with the objectives to refine data collection procedures and to serve as a practice run for clinicians involved in the trial; as well as a substantive trial beginning in December 2016. The 12-item General Health Questionnaire (GHQ-12) was established as a 'fairly accurate' screening tool using a Receiver Operating Curve study. Using the GHQ scoring method of 0-0-1-1, a threshold of 1/2 was identified for use in clinical setting, i.e. the context of the trial. The primary outcome was the health and social functioning of participants as measured by the Health of the Nation Outcome Scale (HoNOS) and secondary outcomes were disability as measured by WHO Disability Assessment Schedule 2.0 (WHODAS 2.0), quality of life as measured by European Quality of Life Scale (EQ‐5D-3L), and cost of intervention evaluated from a health services perspective, which aimed to determine the clinical effectiveness and cost-effectiveness of both frameworks at six months. Results During the recruitment period, 4944 adult primary care patients attended 27 participating primary care centres. Following screening (n=1484) and in-depth psychiatric interviews (n=394), 174 WHO mhGAP arm and 151 Specialist arm participants received a formal diagnosis and were recruited into the trial. The number of required participants per treatment arm, to provide statistical power of 0.80 and statistical bilateral significance value of 0.05 was estimated to be 96. A total of 153 participants of the WHO mhGAP arm and 141 of the Specialist arm were followed-up at six months, representing 90.8% of all participants diagnosed. At follow-up, 82% (n=126) participants of the WHO mhGAP arm indicated they had attended at least one treatment session during the trial, significantly more than in the Specialist Arm (69%; n=97), 2 = 7.364, p=0.007. The WHO mhGAP arm was proven to be statistically not inferior to the Specialist arm in reducing symptoms of social and physical impairment, reducing disability, and improving health-related quality of life at six months. Cost-effectiveness analyses show that the Specialist arm was dominant for a unit of improvement in patient outcomes at six months. While the framework is more expensive for the Health System, participants in the Specialist arm were found to have larger improvements. Conclusion Given that both frameworks yielded positive patient outcomes, there is no immediate need to increase the absolute number of specialist mental health professionals in community psychiatry (i.e. replicate the specialist framework outside Yogyakarta). As most psychologists and psychiatrists in Indonesia reside in large cities, the current systematic roll-out of the adapted WHO mhGAP framework might address the need to strengthen non-stigmatising mental health care within community contexts, reflecting the preferences of primary care patients. In districts or provinces which could afford the additional cost, however, the Specialist framework was shown to be better at improving patient outcomes than the adapted WHO mhGAP framework. Existing resources for specialist care can be arranged in a hub-and-spoke (step-up care) model where higher-level interventions are provided for those with greater needs. The proposed model would free-up resources for advanced clinical training of the specialist workforce in key areas of need while keeping specialist services accessible. Trial Registration This trial has been registered with clinicaltrials.gov since 25 February 2016, NCT02700490. Ehical Standards Full ethics approval from the University of Cambridge, UK was received on 15 December 2015 (PRE.2015.108) and from Universitas Gadjah Mada, Indonesia on 14 April 2016 (1237/SD/PL.03.07/IV/2016). A condition of ethics approval from the University of Cambridge is that the investigator is covered by indemnity insurance and that participants are insured for the period of their participation. This was provided by the University of Cambridge Trial Insurance Office (609/M/C/1510). Ethics approval from all the clusters was not required as each cluster (Puskesmas) is a local GP surgery which does not have its own ethics committee. Instead, approval to conduct research at the province of Yogyakarta including all five districts: Kota Yogyakarta, Sleman, Gunung Kidul, Kulon Progo, Bantul Districts was obtained from the Provincial Government Office (070/REG/V/625/5/2016) following ethics approvals. Written consent to participate was obtained from clinicians taking part as well as all patient-participants.

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Daures, Maguy. "Évaluation d'une stratégie de prise en charge simplifiée de la malnutrition aiguë chez des enfants de 6 à 59 mois en Afrique Sub-saharienne dans le cadre d’un programme de recherche co-construit entre humanitaires et chercheurs". Electronic Thesis or Diss., Bordeaux, 2024. http://www.theses.fr/2024BORD0067.

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La malnutrition aiguë (MA) est un défi mondial, touchant 45 millions d'enfants de moins de 5 ans et est une cause sous-jacente de 800 000 décès annuels. Les protocoles de prise en charge, bien que efficaces, souffrent d'un financement insuffisant et d'une couverture limitée. Ces protocoles divisés en deux programmes pour les enfants malnutris aigus sévères et modérés sont complexes et utilisent des traitements différents avec des dosages non optimaux. Pour répondre à ces défis, l’organisation non gouvernementale (ONG) « The Alliance for International medical action » (ALIMA) a développé le protocole « the Optimizing treatment for acute malnutrition » (OptiMA) visant à traiter tous les enfants présentant un Périmètre Brachial (PB) < 125 mm ou des œdèmes en utilisant un unique aliment thérapeutique prêt à l’emploi (ATPE) avec un dosage dégressif en fonction du PB et du poids. En 2016, ALIMA, l’équipe de recherche GHiGS (Global Health in the Global South, Inserm/IRD/Université de Bordeaux) et le programme PAC-CI à Abidjan, ont fondé le consortium CORAL (Clinical and Operational Research Alliance) visant à co-construire une recherche entre humanitaires et chercheurs dans des pays souvent oubliés par la recherche mondiale en raison de l'instabilité politique et des conflits. Ce travail de thèse explore l'évaluation du protocole OptiMA à travers plusieurs études, dont un essai pilote au Burkina Faso et un essai clinique randomisé au Niger, conduits au sein de CORAL. Un premier essai pilote pragmatique « OptiMA Burkina Faso » mené en 2017 auprès de 4,958 enfants inclus avec PB<125mm ou œdèmes a montré une bonne compréhension de la table de dosage OptiMA à l’échelle d’un district, avec un taux de récupération de 86,3%. Néanmoins, l'absence d'un groupe de comparaison avait souligné la nécessité d'essais cliniques robustes. Le consortium CORAL a alors initié deux essais cliniques dans des contextes différents en République démocratique du Congo (RDC) puis au Niger. Ce travail se concentre sur l'essai OptiMA Niger, qui a évalué les protocoles simplifiés de prise en charge de la MA, comparant OptiMA et la stratégie ComPAS, « The Combined Protocol for Acute Malnutrition Study » (interventions) au protocole national du Niger (contrôle). ComPAS, développé par l’ONG International Rescue Committee (IRC), propose la même approche qu’OptiMA mais détermine la ration d’ATPE de façon très simplifiée sur la base seule du PB et fournit moins d’ATPE qu’OptiMA. Cet essai de non-infériorité à trois bras, randomisé individuellement et mené à Mirriah, au Niger, en 2021-22, a inclus des enfants de 6 à 59 mois souffrant de MA non compliquée définie par un PB < 125 mm ou des œdèmes. Le critère principal était l’issue favorable à 6 mois, définie comme étant en vie et sans rechute. Le critère secondaire était la récupération chez les enfants avec un PB< 115 mm ou des œdèmes défini au cours des 6 mois par : au moins 4 semaines de traitement, absence de fièvre (>37,5°), absence d'œdèmes et PB≥125 mm pendant deux semaines consécutives. Entre le 31 mars et le 23 décembre 2021, 1 732 enfants avec PB <125 mm ou œdèmes et 1 140 enfants présentant un PB <115 mm ou des œdèmes ont été randomisés (1 :1 :1). Les résultats n’ont pas démontré la non-infériorité pour les critères de jugement mais les trajectoires de gains de poids et de PB similaires 6 mois post randomisation dans les 3 bras suggèrent que la réduction progressive de la supplémentation n'a pas eu d'impact négatif sur la croissance de l’enfant, même les plus vulnérables, alors que 40 % d'enfants supplémentaires pourraient être traités sans que le coût des ATPE n'augmente. Dans cet essai mené au Niger, bien que la non-infériorité (ITT et PP) pour les critères de jugement n'ait pas été démontrée, les gains de poids et de PB similaires 6 mois post randomisation dans les bras ComPAS et contrôle suggèrent que la réduction de la ration de supplémentation (…)
Acute malnutrition (AM) is a major public health concern, affecting 45 million children under 5 years of age. It is an underlying cause of 800,000 deaths each year. Existing treatment protocols, while effective, suffer from insufficient funding and limited coverage. Furthermore, these protocols, divided into two programmes for severe and moderate acute malnourished children, are complex to put in place and use different treatments with sub-optimal dosages. In response to these challenges, the non-governmental organisation (NGO) The Alliance for medical action (ALIMA) has developed the « Optimising treatment for acute malnutrition » (OptiMA) protocol. The OptiMA aims to treat any children presenting Mid-Upper Arm Circumference (MUAC)<125 mm or oedema with a single ready-to-use therapeutic food (RUTF) with degressive dosage according to MUAC and weight In 2016, ALIMA, the GHiGS research team (Global Health in the Global South, Inserm/IRD/University of Bordeaux) in Bordeaux and the PAC-CI programme in Abidjan, founded the CORAL (Clinical and Operational Research Alliance) consortium in order to co-construct research activities between humanitarians and researchers in countries often forgotten by global research due to political instability and conflict. This thesis explores the evaluation of the OptiMA protocol through several studies, including a pilot trial in Burkina Faso and a randomized clinical trial in Niger, conducted within CORAL. A first pragmatic pilot trial "OptiMA Burkina Faso" was conducted in 2017 including 4,958 children with MUAC<125mm or oedema. The study has shown a good understanding of the OptiMA dosing table at district level, which led to a recovery rate of 86.3%. However, the lack of a comparison group was an issue, highlighting the need for more robust clinical trials. The CORAL consortium therefore initiated two clinical trials in different settings in the Democratic Republic of Congo (DRC) and Niger. This thesis work focuses on the OptiMA Niger trial, which evaluated two simplified AM management protocols, namely the OptiMA and the ComPAS "The Combined Protocol for Acute Malnutrition Study" strategies (interventions), which were compared with the Niger's national protocol (control). The ComPAS, developed by the NGO International Rescue Committee (IRC) with the same approach as OptiMA, determines the RUTF in a very simplified way, based solely on MUAC, and provides fewer RUTF than OptiMA. This three-arm, individually randomized, non-inferiority controlled trial, conducted in Mirriah, Niger, in 2021-22, included children aged 6-59 months with uncomplicated AM defined by MUAC<125 mm or oedema. The primary endpoint was the « favorable » outcome at 6 months, defined as being alive and without relapse. The secondary endpoint was nutritional recovery in children with MUAC<115 mm or oedema defined over 6 months as at least 4 weeks of treatment, absence of fever (>37.5°) and MUAC≥125 mm and no oedema for two consecutive weeks. Between 31 March and 23 December 2021, 1,732 children with MUAC <125 mm or oedema and 1,140 children with MUAC <115 mm or oedema were randomized (1:1:1). The findings did not demonstrate non-inferiority for any of the main outcomes, but the similar weight and MUAC gains trajectories 6 months post-randomization in the 3 arms suggest that the progressive reduction in supplementation did not have a negative impact on growth, even for the most vulnerable children, whereas 40% more children could be treated without increasing the cost of RUTFs. These trials have provided scientific evidence needed to scale up simplified protocols in emergency health setting. The CORAL consortium demonstrated its strength through the implementation of individually randomized clinical trials conducted rigorously in complex areas

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Deak, Stefan, e Glenn Kristoffersson. "Rädslan för det som finns och inte finns : En randomiserad kontrollerad jämförelse av utfall mellan sedvanlig ensessionsbehandling och behandling med virtuella stimuli mot spindelfobi". Thesis, Stockholms universitet, Psykologiska institutionen, 2016. http://urn.kb.se/resolve?urn=urn:nbn:se:su:diva-130712.

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Specifik fobi är en vanlig psykiatrisk åkomma som kan leda till stora individuella begränsningar. Symtomen kan framgångsrikt behandlas med kognitiv beteendeterapi där 85–90 % blir kliniskt signifikant förbättrade. Forskning påvisar lovande behandlingsutfall för virtuell exponeringsbehandling (VRET) mot spindelfobi. Tekniken är intressant då den kringgår de problem med anskaffning och förvaring av fobiska stimuli som sedvanlig behandling medför och dessutom kan innebära ökad tillgänglighet och flexibilitet vid behandling. Syftet med föreliggande studie är att jämföra behandlingseffekten av ensessionsbehandling (OST) med en nyutvecklad spelifierad virtuell exponeringsbehandling (VIMSE), som sker under en fristående behandlingssession. Totalt randomiserades 73 deltagare mellan de två behandlingsmetoderna. Båda behandlingarna medförde statistiskt signifikanta förbättringar med stora effektstorlekar för såväl det beteendetest (BAT), som utgjorde det primära utfallsmåttet (OST d = 1,94; VIMSE d = 1,41), som för de sekundära utfallsmåtten Spider Phobia Questionnaire och Fear of Spiders Questionnaire. OST resulterade i signifikant fler kliniskt signifikant förbättrade än VIMSE.
VIMSE (VIrtual reality Method for Spider phobia Exposure therapy)

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Nohlert, Eva. "Smoking Cessation : Treatment Intensity and Outcome in Randomized Clinical Trials". Doctoral thesis, Uppsala universitet, Centrum för klinisk forskning, Västerås, 2013. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-208972.

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The primary aim was to compare the effectiveness of smoking cessation interventions of different intensities in a clinical dental and a telephone setting in Sweden. Methods: A total of 300 smokers were randomized to High or Low Intensity Treatment (HIT or LIT) at the Public Dental Service, County Council of Västmanland. Effectiveness (abstinence rate) was measured after 1yr (paper I) and 5-8yrs (paper III). A cost-effectiveness analysis was conducted, based on intervention costs, number of abstinent participants after 1yr, and a Markov modelling of future costs and health (in QALYs) consequences (paper II). In paper IV, 586 callers to the Swedish National Tobacco Quitline (SNTQ) were randomized to high-intensity proactive or low-intensity reactive service, and effectiveness was measured after 1 yr. Effectiveness measures were self-reported point prevalence, 6-month continuous abstinence, and sustained abstinence. Results: Absolute quit rates were 7% higher with HIT than with LIT on all measures and increased by 8% from 1yr to 5-8yrs. Point prevalence was 23% vs. 16% (p=.11) after 1yr and 31% vs. 24% (p=.16) after 5-8yrs. Six-month continuous abstinence was 18% vs. 9% (p =.02) after 1yr and 26% vs.19% (p=.18) after 5-8yrs. Sustained abstinence was 12% vs. 5% (p =.03) after 5-8yrs. Nicotine dependence was a strong predictor for abstinence at 1yr and achieved abstinence at 1yr was a strong predictor for abstinence at long-term follow-up. The cost-effectiveness analysis showed that both HIT and LIT were cost-effective, and LIT was even cost-saving compared with doing nothing. HIT was more costly and more effective than LIT, and the cost of each extra QALY gained by HIT was 100,000SEK, which is considered very cost-effective in Sweden. Proactice and reactive services were equally effective at the SNTQ. Point prevalence was 27% and 6-month continuous abstinence was 21% after 1yr. Being smoke-free at baseline was the strongest predictor for abstinence at 1yr. Conclusion: Support at high as well as low intensity in a clinical dental setting in Sweden and at the SNTQ was effective in achieving smoking cessation. Both high- and low-intensity interventions were very cost-effective in a clinical dental setting.

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Walid, Rania. "Impact Evaluation in Post-conflict Environments : A Critical Appraisal of Randomised Controlled Trial (RCT)". Thesis, Linnéuniversitetet, Institutionen för samhällsstudier (SS), 2021. http://urn.kb.se/resolve?urn=urn:nbn:se:lnu:diva-104816.

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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.

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Spieth, Peter Markus, Anne Sophie Kubasch, Ana Isabel Penzlin, Ben Min-Woo Illigens, Kristian Barlinn e Timo Siepmann. "Randomized controlled trials - a matter of design". Saechsische Landesbibliothek- Staats- und Universitaetsbibliothek Dresden, 2017. http://nbn-resolving.de/urn:nbn:de:bsz:14-qucosa-215848.

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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.

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Spieth, Peter Markus, Anne Sophie Kubasch, Ana Isabel Penzlin, Ben Min-Woo Illigens, Kristian Barlinn e Timo Siepmann. "Randomized controlled trials - a matter of design". Dove Medical Press, 2016. https://tud.qucosa.de/id/qucosa%3A29007.

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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.

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Featherstone, Katie. "Patient perspectives of participation in a randomised controlled trial". Thesis, University of Bristol, 2000. http://hdl.handle.net/1983/06229618-6e8d-4764-8c7a-1f0c0d0af307.

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Schuh, Sr Matthew Anderson. "The Epistemic Necessity and Ethical Permissibility of Randomized Clinical Trials: A Minimalist Defense". Scholarly Repository, 2008. http://scholarlyrepository.miami.edu/oa_dissertations/167.

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I argue for two main theses that are at odds with the positions of many clinical researchers and philosophers who write on the ethics of clinical research. The first is that certain types of clinical trials, namely, randomized clinical trials with double or triple blinding and a placebo group are generally necessary to establish that a medical intervention is effective in treating a certain type of disease or disorder. The second main thesis is that such trials are generally not ethically impermissible. My minimalist defense of clinical trials differs from most defenses of clinical trials found in the literature. I feel that the ethical permissibility of clinical trials can be judged by answering yes to the following questions: 1) Is the potential experimental subject competent to exercise his autonomy and his right of self determination in order to enroll in the clinical trial? 2) Is the potential experimental subject informed about the nature of risk and benefit involved in his participation in the clinical trial? 3) Is the trial scientifically/ epistemically valid? 4) Will the trial attempt to answer a scientific question or questions of value? I argue that competent persons have the right to enroll in scientifically valid clinical trials so long as they are informed and consent to participate.

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Slater, Karen. "Improving Care of Peripheral Intravenous Needleless Connectors". Thesis, Griffith University, 2022. http://hdl.handle.net/10072/412414.

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Background: Most hospitalised patients have a peripheral intravenous catheter (PIVC) at some point during hospitalisation. Although the rate of bloodstream infection (BSI) for PIVCs is low, the sheer number of devices inserted makes them a device of interest, since cumulatively many infections occur worldwide each year. Access to intravenous (IV) lines for the administration of medication and fluids in most of the developed world is through the needleless connector (NC) component of a PIVC. NCs were introduced several decades ago to reduce the risk of needlestick injuries amongst healthcare workers. Although they have been successful in reducing needlestick injuries, there has been an unintended consequence of NCs being associated with increased patient BSI. Patient BSI leads to prolonged length of hospital stay and higher costs, as well as significant morbidity and mortality. About half of all BSIs are attributed to the insertion process and half to on-going maintenance care. One of the most important aspects of maintenance care is NC disinfection, which should take place prior to each access of the NC. When disinfection does not occur, or is inadequate, there is a risk of microorganisms gaining access to the patient’s bloodstream. The optimal cleaning duration and disinfectant agent for NC disinfection have not been established. There have been many laboratory-based studies of NC disinfection but few in the clinical environment. Establishment of the optimal disinfectant agent and disinfection duration is vital to prevent patient BSI and improve patient outcomes. It is also important to establish current practice and identify how this compares to best practice guidelines and what factors influence clinicians’ practice behaviours, since providing evidence-based practice is vital to improve patient outcomes and decrease the risk of patient BSI.Aims and Objectives The aim of this PhD was to establish the most effective method for disinfection of PIVC NCs in the clinical environment and to examine current local infection prevention practices to improve NC care. The research findings will inform healthcare worker practice in the care of PIVC NCs to prevent BSIs. Four objectives guided the three phases of the research: 1. To determine the most effective active disinfectant agent and scrub time to disinfect NCs; 2. To establish adequate NC drying times after disinfection; 3. To evaluate current local practice of PIVC NC care; and 4. To identify nurses’ self-reported practice and attitudes regarding NC care and identify factors that influence their behaviour. Design: This PhD had a multi-method research design. It was underpinned by the Mitchell and Gardiner Infection Prevention and Control conceptual framework. This framework entails a multi-faceted approach to infection prevention. There were three phases to this research: a factorial randomised controlled trial (RCT) comparing disinfectant solutions and disinfectant times, with an associated NC drying time experimental study; an observational study to establish local PIVC care; and finally, a survey of nurses’ practice and attitudes about NC care. Phase 1, Part 1: Research questions: 1. What disinfection agent, 70% isopropyl alcohol (IPA) or 2% chlorhexidine in 70% alcohol (CHG-IPA), is more effective in eliminating microorganisms on PIVC NCs? 2. What disinfection time (5, 10, or 15 seconds) is most effective in eliminating microorganisms on PIVC NCs? Setting: Tertiary adult hospital in Brisbane, Australia. Sample: 300 NCs on PIVCs of adult in-patients located on the internal medical units. Main findings: There was no statistical difference between 70% IPA and 2% CHG in 70% IPA (p = .62) in disinfecting the external surface of NCs in the clinical environment; both were effective, but neither removed all microorganisms. There was no statistical difference in the effectiveness of 5, 10, or 15 (p = .21) second scrub times. Phase 1, Part 2 Research questions: 1. What is the effective drying time of 70% IPA, 2% CHG in 70% IPA, and 10% povidone iodine for NC disinfection? 2. Does the drying time of the three recommended disinfectants differ? Setting: Non-clinical area of tertiary adult hospital in Brisbane, Australia Sample: Three commonly available disinfectant preparation pads/wipes were compared. Main findings: The drying time of the three tested disinfectants differed substantially. After a 15-second scrub, 70% IPA was consistently dry after 5 seconds and 2% CHG in 70% IPA was consistently dry after 20 seconds. Drying time for povidone iodine 10% was not established, as it remained wet at 6 minutes, making its use clinically unfeasible. Phase 2 Research questions: 1. How often do nurses decontaminate their hands prior to accessing PIVC NCs (Moment 2 of the 5 Moments of Hand Hygiene)? 2. How often do nurses disinfect PIVC NCS prior to accessing them? 3. What is the length of time that nurses spend disinfecting PIVC NCs prior to accessing them? 4. What is the length of time that nurses let NCs dry after disinfection, prior to accessing them? Setting: Tertiary adult hospital in Brisbane, Australia Sample: 108 observations of nurses working in the emergency department, two medical wards, and two surgical wards. Main findings: Compliance with disinfection of NCs was high (99%), although disinfection time was a much shorter duration than that recommended in the hospital policy (average 6.1 seconds vs 15 seconds). Compliance with hand hygiene prior to drawing up medication (33%) and immediately prior to medication administration (43%) was suboptimal. The most common duration that nurses allowed NCs to dry was 6–10 seconds. Working in the emergency department setting and use f gloves were associated with poorer compliance with hand hygiene.Phase 3: Research questions: 1. What are nurses’ self-reported practices of NC care? 2. How do self-reported practices of NC care compare to current clinical guidelines and results from previous studies? 3. What influences nurses’ behaviour in relation to NC care and how does this compare to previous studies? Setting: Tertiary adult hospital in Brisbane, Australia Sample: Registered and Enrolled nurses working within the clinical divisions. Main findings Most nurses (89%) stated that they always disinfect NCs prior to access. Nurses’ ability to recognise and undertake the correct sequencing for clamping and line/syringe disconnection was low; 79% of nurses identified the correct clamping and disconnection for negative pressure NCs, and 34% identified the correct sequencing for positive pressure devices. Nurses’ behaviour was most influenced by other senior nurses. The risk of introducing bacteria into the patient’s bloodstream was of great concern to most nurses. Conclusion: PIVC-associated BSI, reflecting suboptimal PIVC maintenance care, remains a serious problem. The results of this PhD focusing on NC disinfection highlight that NCs in the clinical environment are frequently contaminated with microorganisms found on the skin. The RCT—the first on this topic undertaken in a clinical environment—determined that the disinfectants and timeframes tested were very effective in removing most microorganisms from NCs in the clinical environment, but there was no difference between the disinfectants or application durations trialled. The drying time study—the first to examine drying time for commonly used disinfectant preparation pads/wipes on NCs—determined that IPA had the shortest drying time. The observational study established that most nurses disinfect NCs prior to access, but for a shorter duration than is currently recommended. Hand hygiene associated with NC care was suboptimal. The survey—the first comprehensive Australian study—established significant nursing knowledge gaps in NC care and identified opportunities for improvement (particularly the sequencing of disconnecting and clamping NCs and lines), which has the potential to reduce BSIs; it also established that local senior nurses were most likely to influence behaviour. Maintenance care of PIVC NCs has previously been minimally researched and is likely the missing link in infection prevention strategies. This PhD has provided comprehensive new evidence and attention now needs to be directed toward improving the maintenance care of NCs to reduce patient BSI and improve patient safety.
Thesis (PhD Doctorate)
Doctor of Philosophy (PhD)
School of Nursing & Midwifery
Griffith Health
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11

Rickard, Claire. "Prolonged use of intravenous administration sets: a randomised controlled trial". Thesis, Queensland University of Technology, 2004. https://eprints.qut.edu.au/15974/1/Claire_Rickard_Thesis.pdf.

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The purpose of this research study was to improve the nursing care of intravenous catheters by providing evidence on the effects of prolonged duration of intravenous administration set use. Intravenous therapy is a vital part of modern health care. However, its invasive nature can result in infection, with high associated morbidity and mortality. The highest infection rates are displayed in intensive care patients with central venous catheters. The duration of intravenous administration set use may have an impact on infection rates,however the current practice usage and the optimum duration of use is unknown. Previous studies of central venous catheters have reported equal infection rates with 1 to 4 days of administration set use; however few patients have been evaluated with administration sets used beyond this time. Previous research has been limited by the inadequacy of available definitions for Catheter-Related Infection. A prospective, randomised, controlled clinical trial was performed to assess the infection risk of using administration sets for prolonged periods. In the developmental phase prior to the clinical trial; definitions of Catheter-Related Bloodstream Infection (CRBSI) were developed; a nursing practice survey was undertaken to establish the current duration of administration set use; and laboratory experiments were executed to assess the impact of prolonged use on administration set physical integrity and performance. Central venous catheters were randomised to have their administration sets used for 4 days (n = 203) or 7 days (n = 201). Percutaneous central venous catheters were enrolled into the study from two adult intensive care units at a metropolitan, tertiary-referral, teaching hospital. Catheters were multiple-lumen, chlorhexidine-gluconate and silver-sulphadiazine coated lines, both inserted and removed in the intensive care unit. Catheters were cultured for microbial colonisation on removal using the Maki roll-plate technique. Patients were assessed for CRBSI using the developed definitions consisting of categories: definite, probable (type I and II), possible and absent. Prior to the clinical trial, a practice survey questionnaire was administered, and laboratory experimentation was performed. Normality of distribution for continuous variables was assessed using the Kolmogorov- Smirnov statistic. The distribution between groups of variables considered risk factors for Catheter-Related Infection were tested to assess for bias using Chi-square and T-test. Logistic regression modelling was performed to analyse the influence of potentially confounding variables. The incidence of catheter colonisation and CRBSI was tested between groups using Kaplan-Meier survival curve with Log-rank test. Paired T-tests were performed to test for difference in programmed and delivered volumes of administration sets. A general linear model (ANOVA)± a Scheffe post hoc test to isolate difference was fitted to the standardised values of delivered volumes to determine the effects of day of measurement and volume delivery rate on the accuracy of volume delivery. There were 10 colonised tips in the intervention group and 19 in the control group. This difference was not statistically significant (Kaplan Meier survival analysis, Log Rank = 0.87, df = 1, p = 0.35). There were 3 cases of CRBSI per group and the difference in survival from CRBSI was not statistically significant (Kaplan Meier with Log Rank test, p = 0.86). The pre-clinical trial phases of the research programme established that current clinical practice was 3 to 7-day use of administration sets; that administration sets were physically intact and delivered clinically accurate volumes after 7 days of use; and developed useful definitions of CRBSI. Prolonged intravenous administration set use of 7 days was found to have no significant impact on patient infection indicators or physical performance of the sets. This finding is congruent with previous research and trends in current clinical practice. In conclusion, the research findings support the use of intravenous administration sets for 7 days.

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12

Rickard, Claire. "Prolonged use of intravenous administration sets: a randomised controlled trial". Queensland University of Technology, 2004. http://eprints.qut.edu.au/15974/.

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The purpose of this research study was to improve the nursing care of intravenous catheters by providing evidence on the effects of prolonged duration of intravenous administration set use. Intravenous therapy is a vital part of modern health care. However, its invasive nature can result in infection, with high associated morbidity and mortality. The highest infection rates are displayed in intensive care patients with central venous catheters. The duration of intravenous administration set use may have an impact on infection rates,however the current practice usage and the optimum duration of use is unknown. Previous studies of central venous catheters have reported equal infection rates with 1 to 4 days of administration set use; however few patients have been evaluated with administration sets used beyond this time. Previous research has been limited by the inadequacy of available definitions for Catheter-Related Infection. A prospective, randomised, controlled clinical trial was performed to assess the infection risk of using administration sets for prolonged periods. In the developmental phase prior to the clinical trial; definitions of Catheter-Related Bloodstream Infection (CRBSI) were developed; a nursing practice survey was undertaken to establish the current duration of administration set use; and laboratory experiments were executed to assess the impact of prolonged use on administration set physical integrity and performance. Central venous catheters were randomised to have their administration sets used for 4 days (n = 203) or 7 days (n = 201). Percutaneous central venous catheters were enrolled into the study from two adult intensive care units at a metropolitan, tertiary-referral, teaching hospital. Catheters were multiple-lumen, chlorhexidine-gluconate and silver-sulphadiazine coated lines, both inserted and removed in the intensive care unit. Catheters were cultured for microbial colonisation on removal using the Maki roll-plate technique. Patients were assessed for CRBSI using the developed definitions consisting of categories: definite, probable (type I and II), possible and absent. Prior to the clinical trial, a practice survey questionnaire was administered, and laboratory experimentation was performed. Normality of distribution for continuous variables was assessed using the Kolmogorov- Smirnov statistic. The distribution between groups of variables considered risk factors for Catheter-Related Infection were tested to assess for bias using Chi-square and T-test. Logistic regression modelling was performed to analyse the influence of potentially confounding variables. The incidence of catheter colonisation and CRBSI was tested between groups using Kaplan-Meier survival curve with Log-rank test. Paired T-tests were performed to test for difference in programmed and delivered volumes of administration sets. A general linear model (ANOVA)± a Scheffe post hoc test to isolate difference was fitted to the standardised values of delivered volumes to determine the effects of day of measurement and volume delivery rate on the accuracy of volume delivery. There were 10 colonised tips in the intervention group and 19 in the control group. This difference was not statistically significant (Kaplan Meier survival analysis, Log Rank = 0.87, df = 1, p = 0.35). There were 3 cases of CRBSI per group and the difference in survival from CRBSI was not statistically significant (Kaplan Meier with Log Rank test, p = 0.86). The pre-clinical trial phases of the research programme established that current clinical practice was 3 to 7-day use of administration sets; that administration sets were physically intact and delivered clinically accurate volumes after 7 days of use; and developed useful definitions of CRBSI. Prolonged intravenous administration set use of 7 days was found to have no significant impact on patient infection indicators or physical performance of the sets. This finding is congruent with previous research and trends in current clinical practice. In conclusion, the research findings support the use of intravenous administration sets for 7 days.

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Henderson, Neil James Kerr. "Extending the clinical and economic evaluations of a randomised controlled trial the IONA study /". Connect to e-thesis, 2008. http://theses.gla.ac.uk/418/.

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Thesis (Ph.D.) - University of Glasgow, 2008.
Ph.D. thesis submitted to the Department of Statistics, Faculty of Information and Mathematical Sciences, University of Glasgow, 2008. Includes bibliographical references. Print version also available.

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Parkin, Nicola Ann. "Open versus closed exposure of palatally displaced canines : a randomised clinical trial". Thesis, University of Sheffield, 2012. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.575857.

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Purpose: To investigate the differences in outcomes between Open and Closed exposures of PDC. The primary outcome assessed is periodontal health; secondary outcome measures include economics and patient response. Methods: A multicentre randomised controlled trial involving two parallel groups. The settings were one dental teaching hospital (Charles Clifford Dental Hospital, Sheffield) and two regional peripheral hospital units. Individuals aged under 20 years with unilateral PDC were identified as potential participants using specific inclusion and exclusion criteria. Those patients or their parents who gave informed consent to take part in the study were randomly allocated to either receive the Open or Closed surgical procedure. Periodontal outcomes included Clinical attachment levels, gingival recession, crown height and aesthetic ratings (judqed by orthodontists and lay persons). Economic outcomes were calculated from information given from Trust Accountants, length of time spent in the operating theatre and number of visits required to complete orthodontic treatment. Patient response was assessed using a 10 day post-operative questionnaire. Results: Eighty-one participants were enrolled (Closed = 41, Open =40). Ten patients did not receive palatal surgery (Closed = 5, Open = 5) therefore the maximum number of participants in any analysis was 71. The results of each outcome measure have been summarised according to the order of data collection. Theatre times were obtained from 57 out of the 71 participants who underwent surgery (Closed 26, Open 31). The mean surgical time was virtually identical between the two groups (Closed 34.3 mins, SD 11.9; Open 34.3 mins, SD 11.2), which was not statistically different (independent t test; P = 0.986). There were no differences in number of orthodontic visits required to move the PDC into the line of the arch (P= 0.516) nor were there any differences in cost to the NHS according to the HRG4 2011/12 Report. There were no significant differences between the Closed and Open groups for any of the patient reported outcomes.Difficulty brushing was the most frequently reported impact on every day activities. In terms of pain, the majority of the responses (36 out of 60) claimed that post-operative pain lasted for several days but less than a week. In terms of the primary outcome measure, the periodontal outcome, statistical differences were found in six point clinical attachment levels between the treated canine and the untreated contra-lateral canine. The mean difference was = 0.6mm, P=0.001. However, no differences were found when Closed and Open groups were compared (P=0.782). For the other periodontal parameters measured, including the aesthetic analysis, no differences were found between Closed and Open groups. Conclusions: There were no differences in any of the outcomes investigated in this study between Closed and Open surgical techniques for PDC.

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Handley, Alicia Katherine. "A randomised controlled trial of group cognitive behavioural therapy for clinical perfectionism". Thesis, Curtin University, 2014. http://hdl.handle.net/20.500.11937/802.

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This thesis consisted of two linked studies. The first study examined the relationship between perfectionism and generalised anxiety disorder symptoms in a clinical sample. Perfectionism demonstrated significant associations with pathological worry and a principal diagnosis of generalised anxiety disorder. The second study examined the efficacy of group cognitive behavioural therapy for clinical perfectionism in a clinical sample. This treatment produced significant reductions in perfectionism and psychopathology and significant increases in self-esteem and quality of life.

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Acharya, Dev Raj. "Measuring the effectiveness of teaching sex education in Nepalese secondary schools : an outcome from a Randomised Controlled Trial (RCT)". Thesis, Aberystwyth University, 2014. http://hdl.handle.net/2160/7aed061b-668e-4789-879e-b30ba401b6c6.

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This study aimed to identify the effectiveness of delivering sex education in secondary schools in Hetauda (Nepal) by exploring the sexual health knowledge and understanding of young people, and parents' and teachers' views on sex education, in order to place the findings in the wider social, cultural and educational context of modern Nepal. The research selected four secondary schools pupils of diverse sociobackground characteristics in Hetauda municipality, central Nepal. This study was conducted by undertaking an intervention in control (2 schools) and experiment (2 schools) groups, and as such constituted the quantitative method. Semi-structured Key Informant Interviews (KIIs) with 14 key stakeholders (6 parents and 8 teachers) and 8 Focus Group Discussions (FGDs) with 78 pupils constituted the qualitative method. Quantitative and qualitative data were analysed separately by utilising statistical software (SPSS, 19) and thematic analysis, respectively. Outcomes were compared, combined and discussed. This study relies on a multiple theory platform (cognitive constructivism, social constructivism and social cognitive theory) to evaluate the effectiveness of sex education delivery in schools. The conventional teacher in the control school delivered the sex education programme in a didactic approach. The result had less impact on pupils' sexual health knowledge and understanding. In contrast, the health facilitator-led experimental schools used a participatory approach which showed a reasonable knowledge increment around sexual health. However, the pupils were still confused and uncertain about how to obtain sexual health information from relatives of a similar age and their family members. Many parents lacked the knowledge, iv confidence and skills to offer meaningful support to their children. This study noted four main important influential sexual health attitudes and behaviours of the pupils: ambiguous social roles leading to confusion; increased sexual awareness and curiosity about sex; significant gaps in knowledge and behaviour; and limited parental input. This study suggested several possible approaches that could be developed to improve sex education in Nepal. Young people need more information on the risk of Sexually Transmitted Infections (STIs) and unwanted pregnancies. This could encourage them to gain more sexual health knowledge which in turn could lead to increased engagement in safer sexual health practices. In particular, more young girls should be provided with access to sexual health knowledge and services in order to achieve real improvements in pupils' sexual health. Furthermore, attention needs to be given to rigorous research and appropriate sex education interventions in school. Integrating sex and relationship education, both in formal and informal education, could help to improve young people's sexual and reproductive health status.

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Woodford, Joanne. "Development and feasibility randomised controlled trial of guided Cognitive Behavioural Therapy (CBT) self-help for informal carers of stroke survivors". Thesis, University of Exeter, 2014. http://hdl.handle.net/10871/17401.

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Background: One-in-three carers of stroke survivors experience depression with no psychological treatments tailored to meet their needs, such as barriers to attending traditional face-to-face psychological services. A cognitive behavioural therapy (CBT) self-help approach may represent an effective, acceptable solution. Methods: Informed by the MRC framework (2008) for complex interventions, six studies informed development, feasibility and piloting of a CBT self-help intervention for depressed carers of stroke survivors: Study One: Systematic review and meta-analysis of psychological interventions targeting depression and anxiety in carers of people with chronic health conditions; Study Two: Interviews to understand difficulties experienced by depressed and anxious carers; Study Three: Interviews to understand positive coping strategies used by non-depressed and non-anxious carers; Study Four: Drawing on results of Studies One to Three, iterative modelling to develop the CBT self-help intervention; Study Five: Feasibility randomised controlled trial to examine methodological and procedural uncertainties for a Phase III definitive trial; Study Six: Updated systematic review and meta-analysis. Results: Study One: 16 studies identified for inclusion yielding small and medium effect sizes for depression and anxiety respectively, with trends for individually delivered treatments over shorter session durations to be more effective for depression. Six additional studies were included in Study Six, replicating Study One results; Study Two: Depressed and anxious carers experience difficulties adapting to the caring role, managing uncertainty, lack of support and social isolation; Study Three: Non-depressed and non-anxious carers utilise problem-focused coping strategies to gain balance and adapt to caring role, use assertiveness, seek social support and positive reinterpretation; Study Four: Developed a theory-driven CBT self-help intervention; Study Five: Recruited 20 informal carers in 10-months, representing 0.08% of invited carers randomised with high attrition in the intervention arm. Lack of GP recognition, gatekeeping and barriers to accessing psychological support identified as reasons for poor recruitment. Conclusions: A greater appreciation is required concerning barriers experienced by informal carers of stroke survivors to accessing support for depression and type of acceptable psychological support.

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Tohotoa, Jennifer Lynn. "The development, implementation and evaluation of a father inclusive perinatal support intervention to increase breastfeeding duration : a randomised controlled trial". Thesis, Curtin University, 2012. http://hdl.handle.net/20.500.11937/1542.

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Breastfeeding is the biological norm for infant feeding and the most efficient and cost-effective method of giving the required nutrition to infants. The World Health Organization, the American Academy of Paediatrics and the National Health and Medical Research Council recommend exclusive breastfeeding for six months and the continuation of complementary foods for up to two years. Although most developed countries maintain high initiation rates, the duration rates fail to meet these recommendations. The promotion of breast milk substitutes, changing societal values, urbanization, and the erosion of traditional support systems pose threats to breastfeeding. In Australia the breastfeeding initiation rates are between 85%-95% but fall to 20%-45% by six months. There is some evidence that fathers, the primary support to their partners, influence the initiation and maintenance of breastfeeding by their partners. There has been little research in this area, however, with little known about the nature of a father’s support required by the mother and few interventions have specifically targeted fathers.The present thesis describes the development, implementation and evaluation of a father inclusive perinatal support intervention at six weeks postnatal. The project was conducted over three years as a randomised controlled trial (RCT) across eight public maternity hospitals in Perth, Western Australia.

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McArdle, Gerarde T. "A prospective randomised clinical trial comparing undergoing electric infrarenal abdominal aortic aneurysm repair". Thesis, Queen's University Belfast, 2011. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.534687.

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Guarino, Peter David. "Consumer participation in the design of informed consent documentation for entry into randomised clinical trials : a cluster randomised trial". Thesis, London School of Hygiene and Tropical Medicine (University of London), 2005. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.422313.

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Watson, Hunna J. "Clinical and research developments in the treatment of paediatric obsessive-compulsive disorder". Thesis, Curtin University, 2007. http://hdl.handle.net/20.500.11937/2374.

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It is of crucial importance to identify and disseminate effective treatments for paediatric obsessive-compulsive disorder (OCD). OCD is time-consuming and distressing, and can substantially disable functioning at school, at home, and with peers (Piacentini, 2003). Children who do not receive treatment are at risk of psychological difficulties in adulthood, including continued OCD, clinical anxiety and depression, personality disorders, and social maladjustment (Wewetzer et al., 2001). Two-thirds of adult cases of OCD develop in childhood, and adults with OCD have lower employment, poorer academic achievement, and lower marital rates compared to non-OCD adults (Hollander et al., 1996; Koran, 2000; Lensi et al., 1996; Steketee, 1993). The distressing nature of OCD in childhood, accompanying psychosocial impairment and risk of future psychopathology, underscore the need to identify effective treatments. The primary aim of this thesis was to expand knowledge of evidence-based treatments for paediatric OCD. A mixed-methodology approach was employed to examine key issues in this area. The first study used meta-analytic methodology to determine the evidence supporting available treatments for paediatric OCD. An extensive literature search revealed over 100 published reports of treatments, encompassing a broad array of theoretical approaches and treatment strategies. Examples of treatments used for paediatric OCD included psychodynamic therapy, pharmacotherapy, cognitive-behavioural therapy (CBT), hypnosis, family therapy, immunotherapy, and homeopathy.Study 1 comprised the first known meta-analysis of randomised, controlled treatment trials (RCTs) for paediatric OCD. Included studies were limited to RCTs as they are the most scientifically valid means for determining treatment efficacy and provide a more accurate estimate of treatment effect by removing error variance associated with confounding variables. The literature search identified 13 RCTs containing 10 pharmacotherapy to control comparisons (N = 1016) and 5 CBT to control comparisons (N = 161). Random effects modelling yielded statistically significant pooled effect size (ES) estimates for pharmacotherapy (ES = 0.48, 95% CI = 0.36 to 0.61, p < .00001) and CBT (ES = 1.45, 95% CI = 0.68 to 2.22, p =.002). The results support the efficacy of CBT and pharmacotherapy, and confirm these approaches as the only two evidence-based treatments for paediatric OCD. Implications and suggestions for future research are discussed. The effectiveness of CBT provided impetus to further examine this treatment. Group CBT is an understudied treatment modality among children with OCD. It was hypothesised that group CBT would possess efficacy because of the effectiveness of individual CBT for children with OCD, the demonstrated effectiveness of group CBT among adults with OCD, the practical and therapeutic advantages afforded by a group treatment approach, and the embeddedness of the approach in robust psychological theory. The aim of the second study was to evaluate the efficacy of group CBT. The study comprised the largest known conducted randomised, placebo-controlled trial of group CBT for paediatric OCD.Twenty-two children and adolescents with a primary diagnosis of OCD were randomly assigned to a 12-week program of group CBT or a credible psychological placebo. Children were assessed at baseline, end of treatment, and at 1 month follow-up. Outcome measures included the Children’s Yale-Brown Obsessive-Compulsive Scale, global measures of OCD severity, Children’s Depression Inventory, and parent- and child-rated measures of psychosocial functioning. An intention-to-treat analysis revealed that children in the group CBT condition had statistically significantly lower levels of symptomatology at posttreatment and follow-up compared to children in the placebo condition. Analysis of clinical significance showed that 91% of children that received CBT were ‘recovered’ or ‘improved’ at follow-up, whereas 73% of children in the placebo condition were ‘unchanged’. Effect size analysis using Cohen’s d derived an effect of 1.14 and 1.20 at posttreatment and follow-up, respectively. These effects are comparable to results from studies of individual CBT. This study supported group CBT as an effective treatment modality for paediatric OCD and demonstrated that the effect extends beyond placebo and nonspecific treatment factors. In addition to treatment efficacy, the inherent worth of a treatment lies in its adoption by the relevant clinical population. Children with OCD are known to be secretive and embarrassed about symptoms, and there is often a long delay between onset of symptoms and treatment-seeking (Simonds & Elliot, 2001). An important observation during the course of conducting the RCT was that a high rate (39%) of eligible families declined participation.This led to the question, "What barriers prevent participation in group CBT for paediatric OCD?" Qualitative methodology was employed to address this research question. Eligible families that had declined participation in the RCT were contacted and invited to participate in semi-structured interviews that explored reasons for non-participation and positive and negative perceptions of group CBT. The average time between non-participation and interview was 1.33 years (SD = 3 months). Data were collected from nine families and thematic analysis methodology was utilised to identify emergent themes. Failure to participate was predicted by practical and attitudinal barriers. Practical barriers included a lack of time, distance, severity of OCD symptoms, financial, and child physical health. Attitudinal barriers included child embarrassment about OCD symptoms, child belief that therapy would be ineffective, fear of the social aspect of the group, lack of previous success with psychology, lack of trust in strangers, parental concern about the structure of the group, denial of a problem, and â€˜not being ready for itâ€™. Attitudinal barriers more frequently predicted treatment non-participation. Positive and negative perceptions of this treatment modality were informative. Parents showed no differences in preference for individual or group CBT. An important finding was that 56% of the children had not received treatment since parental expression of interest in the group CBT program. Application of the findings to methods that promote service utilisation is discussed.

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Hutchison, Catherine B. "A randomised controlled trial of an audiovisual patient information intervention in cancer clinical trials". Thesis, University of Stirling, 2008. http://hdl.handle.net/1893/442.

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Introduction and background Recruitment to cancer clinical trials needs to be improved, as does patient understanding about clinical trials, to enable patients to make an informed choice about whether or not to take part. The main reason that clinically eligible patients do not take part in clinical trials is because they refuse; poor understanding of the research has been associated with patient refusal. Audiovisual patient information (AVPI) has been shown to improve knowledge/understanding in various areas of practice but there is limited information about its effect in the cancer clinical trial setting, particularly in relation to recruitment rates. Understanding the research is necessary for informed consent, and it was hypothesised that if patient understanding about clinical trials was increased with AVPI, then this could result in a reduction in the number of patients refusing clinical trials, and therefore provide an ethical approach to improving recruitment. This study aimed to test the impact of an audiovisual patient information intervention on recruitment to randomised cancer clinical trials (refusal rates), patient understanding of the information given, and levels of anxiety. Reasons for patients’ decisions about trial participation were also assessed. Method An AVPI intervention was developed that aimed to address the common misconceptions associated with randomisation and clinical equipoise, as well as improve patient understanding generally of randomised cancer trials, and of other core clinical trial informational requirements, such as voluntariness. Patients were randomised to receive either AVPI in addition to the standard trial-specific written information, or the written information alone. A new questionnaire was developed to assess patient understanding (also referred to as knowledge) in the randomised trial setting and, following testing with patients and research nurses, this was shown to be reliable and valid. Patients completed self-report questionnaires to assess their understanding (new knowledge questionnaire) and anxiety (Spielberger State-Trait Anxiety Inventory), at baseline and after they had made their decision about clinical trial entry, when their perceptions of the intervention, as well as factors contributing to their decision were also determined (this tool incorporated Jenkins and Fallowfield’s (2005) questionnaire which assessed reasons for accepting and declining randomised cancer trials). Results A total of 173 patients with breast cancer (65%), colorectal cancer (32%) and lung cancer (3%) were entered into the main study. The median age was 60 (range 37-92 years). There was no difference in clinical trial recruitment rates between the two groups: 72.1% in the AVPI group and 75.9% in the standard information group. The estimated odds ratio for refusal (intervention/no intervention) was 1.19 (95% ci 0.55-2.58, p=0.661). Knowledge scores increased more in the intervention group compared to the standard group (U= 2029, p=0.0072). The change in anxiety score between the arms was also statistically significant (p=0.011) with anxiety improving in the intervention arm more than in the no-intervention arm. The estimated difference in the median anxiety change score between the groups is –4.6 (95% ci –7.0 to –2.0). Clinical trial entry was not influenced by tumour type, stage of cancer, age, educational qualifications or previous research experience, however, there was a modest association with deprivation status (p=0.046) where more affluent patients were the least likely to consent to a trial. Educational qualifications and stage of cancer were independently associated with knowledge: patients who were better educated had higher levels of knowledge about randomised trials, and patients who had limited stage of cancer had higher baseline knowledge than patients with advanced cancer. Acceptability of the intervention was high with 93% of those who watched it finding it useful, and 42% stating that it made them want to take part in the clinical trial. Personal benefit and altruism were key motivating factors for clinical trial participation, with reasons for refusal being less clear. Discussion and conclusions Although the potential for AVPI to increase clinical trial recruitment rates was highlighted in the literature, in this study, AVPI was not shown to have any effect on refusal rates to randomised cancer trials. However, by improving patient understanding prior to decision making, AVPI was shown to be a useful addition to the consent process for randomised cancer trials. AVPI addresses the fundamental ethical challenges of informed consent by improving patient understanding, and supports the ethical framework integral to Faden and Beauchamp’s (1986) theory of informed consent. The new knowledge questionnaire was shown to be a sensitive and effective instrument for measuring understanding of randomised clinical trials in the cancer setting, although it would benefit from further testing. The AVPI appears to reduce anxiety at the decision making time point and has been shown to be an acceptable medium for patients. This study confirms existing findings from studies assessing factors affecting decision making, with personal benefit and altruism being key motivating factors, and reasons for refusal being less clear. The need for further qualitative work in this area is highlighted to gain a deeper understanding of what is important to patients, in terms of why they refuse clinical trial participation. Implications for practice and further research Several implications for practice have been identified, including using AVPI as part of the standard information package for patients considering randomised cancer trials, and focussing on patient and staff education in this area. The knowledge questionnaire could be introduced to routine practice as a tool to determine patient understanding prior to decision making, allowing clinicians the opportunity to correct any misconceptions prior to consent. Further research focussing on AVPI specific to individual trials would be helpful, to determine if a more customised approach would be of benefit in terms of clinical trial recruitment. The importance of studying other aspects of the consent process such as the interaction between the clinician and the patient, in addition to more detailed exploration of the factors affecting patients’ decisions were highlighted.

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Henderson, Neil J. K. "Extending the clinical and economic evaluations of a randomised controlled trial : the IONA Study". Thesis, University of Glasgow, 2008. http://theses.gla.ac.uk/418/.

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In modern society people are concerned about their state of health and if they do unfortunately become ill they want the best possible treatment to be made available to them. In order to satisfy these demands new treatments have to be developed. This can be a long and expensive process. Before any new treatment can come to market it has to be proved to be both clinically effective and economically cost-effective. With limited health care resources the cost-effectiveness of treatments is becoming ever more relevant. In order to show whether a treatment is clinically effective a clinical trial is carried out and this is now usually accompanied by an economic evaluation, so that the cost effectiveness of the treatment can be assessed. When a clinical trial aimed at preventing clinical events is analysed, a time-to-first event analysis is often performed together with a cost-effectiveness analysis. These analyses do not always make the best use of the large amounts of patient information recorded during the clinical trial. Using the randomised controlled trial (RCT) the Impact Of Nicorandil in Angina (IONA) as an exemplar, ways in which the clinical and economic evaluations of clinical trials can be expanded are explored. There are three main parts of this thesis. Firstly, following a more detailed introduction in Chapter 1, in Chapters 2 and 3 the IONA Study is introduced and the main clinical results of the study are given. Secondly, in Chapters 4, 5 and 6 the fact that patients could suffer more than one clinical endpoint is considered. The models that can be used to incorporate the recurrent events are introduced and then applied to the data from the IONA Study. Following on from this, through the simulation of recurrent event data, the performance of the models under different known conditions is assessed. Thirdly, in Chapters 7 and 8 an introduction to health economics is given and following this the main results of the economic evaluation of the IONA Study are presented. Areas in which the results of the economic evaluation can be expanded are then investigated. Finally, in Chapter 9 there is a discussion of the work as a whole and areas where there would be the possibility of further work.

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Hoiles, Kimberley Jo. "A Randomised Controlled Trial of Guided Self-Help Cognitive Behaviour Therapy for Clinical Perfectionism". Thesis, Curtin University, 2016. http://hdl.handle.net/20.500.11937/51902.

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Perfectionism has been found to be elevated across disorders, with evidence that it can interfere with treatment outcome. Study 1, provides evidence of convergent validity of the CPQ in a mixed clinical sample (N = 32). In Study 2, guided self-help CBT for clinical perfectionism decreased perfectionism and psychopathology in an elevated perfectionism sample (N = 40) with self-criticism mediating treatment outcome. The intervention also reduced primary DSM-IV diagnosis and comorbid presentations.

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25

Coskinas, Xanthi. "Changes to design aspects of ongoing randomised controlled trials". Thesis, The University of Sydney, 2022. https://hdl.handle.net/2123/29452.

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Unplanned changes to the research plan of a randomised controlled trial (RCT) may be a necessary response to unforeseen circumstances. Such changes can help ensure the value and relevance of a trial, but also have the potential to introduce a bias if performed inappropriately. This thesis addresses three broad aims. The first was to highlight the methodological implications of approaches to making various unplanned changes through a series of simulation studies. The second was to estimate the prevalence of such changes to a contemporary sample of published RCTs registered with the Australian New Zealand Clinical Trial Registry (ANZCTR). The third was to assess, and extend as applicable, recommendations for ensuring such changes are performed appropriately and are well documented. The simulation studies were performed using data from a large RCT of statin therapy for secondary prevention. The first of these demonstrated how unplanned changes (to various aspects of the design such as the primary endpoint) risks introducing a bias if undertaken with knowledge of treatment allocation, but not if made without knowledge of treatment allocation. The second investigated strategies for reacting to an observed imbalance on baseline prognostic factors in an RCT. It demonstrated that: continuing with original plans of unadjusted analyses, provided valid p-values irrespective of the direction of the prognostic imbalance, and any decisions informed by knowledge of the direction of the prognostic covariate imbalance were prone to bias. The third simulation study investigated strategies for reacting to a lower-than-expected event rate. It showed that switching to an expanded composite endpoint in response to a low pooled event rate does not inflate the type 1 error rate (and is likely to improve the statistical power, provided the expanded composite is sound). A sample of 181 RCTs that were registered with the ANZCTR and had published a primary result paper were assessed for changes to their research plans, and whether these changes were legitimate or not (that is, made with or without knowledge of treatment allocation). A full audit was conducted on trials with accessible protocols (N=124) and a limited central review on trials without accessible protocols (N=57). The primary results publication was cross-checked with the protocol documents across six methodological aspects for the full audit, and trialists were contacted to resolve queries as necessary. The publication was checked against the registry record for the limited central review, over a subset of three methodological aspects. A key finding of this study was that it was often not possible to reliably assess whether changes had been made or whether changes were made in a blinded manner, based on review of documentation alone. After clarification was sought from the participating trialists, changes were found to be relatively common but typically made in a blinded manner. Improvements to the way unplanned changes to RCT research plans are documented are needed. A set of recommendations to supplement existing guidelines relating to the documentation of RCT research plans was developed. One key recommendation was that trialists should adopt and implement the principles of the recently developed CONSERVE 2021 Statement to appropriately perform and document substantive changes. A second was that strategies that oblige trialists to upload full protocols (and protocol amendments) to clinical trial registries warrant further investigation and further consideration should be given to including all key methodological aspects in registry records. The work undertaken provides valuable guidance for trialists (and stakeholders) on how to make and document a methodologically justifiable change to a planned RCT design/analysis and highlights the circumstances under which a change can lead to bias. This is important for ensuring that methodically unsound changes to RCTs are recognised and avoided, and that RCTs that have undergone methodically sound changes are not incorrectly dismissed as potentially biased.

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Ferrante, di Ruffano Lavinia. "Using randomised controlled trials to evaluate the clinical effectiveness of diagnostic tests : how useful are test-treatment RCTs?" Thesis, University of Birmingham, 2013. http://etheses.bham.ac.uk//id/eprint/4269/.

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Background: Decisions on which tests to use should be informed by evidence that they do more good than harm. Test-treatment RCTs are recommended as the ‘gold–standard’ approach, but have attracted criticism that question whether they are fit for purpose. Confronting this question, the thesis investigates four key challenges by finding and analysing all identifiable test-treatment RCTs (2004–2007). Methods: Capture–recapture analysis estimated the total population of trials; descriptive analysis characterised the diagnostic questions evaluated by RCT; reviews of reporting and methodological quality investigated how informative and valid trials are; analytic induction was used to develop a theoretical framework linking tests to health outcomes, from which a tool was designed. Results: Published trials were poor quality, and found to be highly complex studies that will be challenging to evaluate reliably: interventions are difficult to capture and translate into protocols; several methods traditionally used to eliminate bias are more difficult to implement; test-treatment strategies impact on patient health in numerous and highly complicated ways. Conclusion: Test-treatment trials have the potential to be very useful instruments, and though highly challenging they could be both reliable and informative. However, it must be acknowledged that trials will not be suited to all comparisons.

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Chuayna, Nonglak. "Implementing clinical guidelines in nurse-led primary health care in Thailand : a randomised controlled trial". Thesis, University of Liverpool, 2003. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.274428.

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Ford, Shane Alwyn. "Delivering Acceptance and Commitment Therapy (ACT) for mental health disorders across group and guided self-help formats : a meta-analysis and randomised controlled trial". Thesis, University of Edinburgh, 2017. http://hdl.handle.net/1842/25924.

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Background: Acceptance and Commitment Therapy (ACT) has shown promise as an effective intervention in the treatment of mental health disorders. In the last decade, the delivery of ACT has expanded to include various formats (e.g. groups, self-help, online and phone apps). Further research is needed to evaluate whether such delivery formats are a viable extension of ACT. Furthermore, the existing evidence base of certain alternative delivery formats have yet to be reviewed. This thesis portfolio sought to contribute to this area of research. Methods: A systematic review of the literature was conducted to investigate the efficacy of group-based interventions for mental health disorders using ACT. Five databases were systematically searched, manual searches were conducted and corresponding authors were contacted. Studies which used a randomised-controlled design, with adult samples and investigated group-based ACT interventions for mental health disorders were included. A meta-analysis of the included studies was conducted for post-intervention and follow-up data. In the empirical study, an ACT manual was trialled using a randomised-controlled design to investigate the efficacy of using ACT in a guided self-help context. Participants with anxiety/depression were randomly assigned to receive either the ACT intervention or treatment as usual (TAU). Those in the ACT group were posted an ACT manual and received two telephone calls. Outcome measures were analysed after the six-week intervention. Results: From the meta-analysis, 18 randomised-controlled trials were identified, 14 of which focussed on anxiety and depression. The findings suggest that ACT-based groups have a large effect on symptom reduction when compared to non-active comparisons at post-treatment and a moderate effect when compared to non-active comparisons at follow-up. Additionally, there was a small effect in favour of ACT when compared to active treatment controls at post-treatment and equivalent effects when comparing ACT to active treatment controls at follow-up. Similar effects were found when separately comparing the 14 studies which focussed primarily on anxiety and depression. The empirical study revealed that guided self-help was found to be no more effective in improving quality of life or reducing psychological distress than the TAU group. However, such results should be interpreted with caution as the small sample size and high attrition rate indicates that further research with larger samples and follow-up are needed before strong conclusions can be made. Conclusions: The findings of this research indicate that group-based ACT interventions may be a suitable alternative delivery format for service providers in the provision of common mental health disorders, particularly anxiety and depression. Further research is needed before any strong conclusions can be made regarding the efficacy of guided self-help for anxiety/depression.

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Watson, Hunna J. "Clinical and research developments in the treatment of paediatric obsessive-compulsive disorder". Curtin University of Technology, School of Psychology, Division of Health Sciences, 2007. http://espace.library.curtin.edu.au:80/R/?func=dbin-jump-full&object_id=115091.

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It is of crucial importance to identify and disseminate effective treatments for paediatric obsessive-compulsive disorder (OCD). OCD is time-consuming and distressing, and can substantially disable functioning at school, at home, and with peers (Piacentini, 2003). Children who do not receive treatment are at risk of psychological difficulties in adulthood, including continued OCD, clinical anxiety and depression, personality disorders, and social maladjustment (Wewetzer et al., 2001). Two-thirds of adult cases of OCD develop in childhood, and adults with OCD have lower employment, poorer academic achievement, and lower marital rates compared to non-OCD adults (Hollander et al., 1996; Koran, 2000; Lensi et al., 1996; Steketee, 1993). The distressing nature of OCD in childhood, accompanying psychosocial impairment and risk of future psychopathology, underscore the need to identify effective treatments. The primary aim of this thesis was to expand knowledge of evidence-based treatments for paediatric OCD. A mixed-methodology approach was employed to examine key issues in this area. The first study used meta-analytic methodology to determine the evidence supporting available treatments for paediatric OCD. An extensive literature search revealed over 100 published reports of treatments, encompassing a broad array of theoretical approaches and treatment strategies. Examples of treatments used for paediatric OCD included psychodynamic therapy, pharmacotherapy, cognitive-behavioural therapy (CBT), hypnosis, family therapy, immunotherapy, and homeopathy.
Study 1 comprised the first known meta-analysis of randomised, controlled treatment trials (RCTs) for paediatric OCD. Included studies were limited to RCTs as they are the most scientifically valid means for determining treatment efficacy and provide a more accurate estimate of treatment effect by removing error variance associated with confounding variables. The literature search identified 13 RCTs containing 10 pharmacotherapy to control comparisons (N = 1016) and 5 CBT to control comparisons (N = 161). Random effects modelling yielded statistically significant pooled effect size (ES) estimates for pharmacotherapy (ES = 0.48, 95% CI = 0.36 to 0.61, p < .00001) and CBT (ES = 1.45, 95% CI = 0.68 to 2.22, p =.002). The results support the efficacy of CBT and pharmacotherapy, and confirm these approaches as the only two evidence-based treatments for paediatric OCD. Implications and suggestions for future research are discussed. The effectiveness of CBT provided impetus to further examine this treatment. Group CBT is an understudied treatment modality among children with OCD. It was hypothesised that group CBT would possess efficacy because of the effectiveness of individual CBT for children with OCD, the demonstrated effectiveness of group CBT among adults with OCD, the practical and therapeutic advantages afforded by a group treatment approach, and the embeddedness of the approach in robust psychological theory. The aim of the second study was to evaluate the efficacy of group CBT. The study comprised the largest known conducted randomised, placebo-controlled trial of group CBT for paediatric OCD.
Twenty-two children and adolescents with a primary diagnosis of OCD were randomly assigned to a 12-week program of group CBT or a credible psychological placebo. Children were assessed at baseline, end of treatment, and at 1 month follow-up. Outcome measures included the Children’s Yale-Brown Obsessive-Compulsive Scale, global measures of OCD severity, Children’s Depression Inventory, and parent- and child-rated measures of psychosocial functioning. An intention-to-treat analysis revealed that children in the group CBT condition had statistically significantly lower levels of symptomatology at posttreatment and follow-up compared to children in the placebo condition. Analysis of clinical significance showed that 91% of children that received CBT were ‘recovered’ or ‘improved’ at follow-up, whereas 73% of children in the placebo condition were ‘unchanged’. Effect size analysis using Cohen’s d derived an effect of 1.14 and 1.20 at posttreatment and follow-up, respectively. These effects are comparable to results from studies of individual CBT. This study supported group CBT as an effective treatment modality for paediatric OCD and demonstrated that the effect extends beyond placebo and nonspecific treatment factors. In addition to treatment efficacy, the inherent worth of a treatment lies in its adoption by the relevant clinical population. Children with OCD are known to be secretive and embarrassed about symptoms, and there is often a long delay between onset of symptoms and treatment-seeking (Simonds & Elliot, 2001). An important observation during the course of conducting the RCT was that a high rate (39%) of eligible families declined participation.
This led to the question, "What barriers prevent participation in group CBT for paediatric OCD?" Qualitative methodology was employed to address this research question. Eligible families that had declined participation in the RCT were contacted and invited to participate in semi-structured interviews that explored reasons for non-participation and positive and negative perceptions of group CBT. The average time between non-participation and interview was 1.33 years (SD = 3 months). Data were collected from nine families and thematic analysis methodology was utilised to identify emergent themes. Failure to participate was predicted by practical and attitudinal barriers. Practical barriers included a lack of time, distance, severity of OCD symptoms, financial, and child physical health. Attitudinal barriers included child embarrassment about OCD symptoms, child belief that therapy would be ineffective, fear of the social aspect of the group, lack of previous success with psychology, lack of trust in strangers, parental concern about the structure of the group, denial of a problem, and â€˜not being ready for itâ€™. Attitudinal barriers more frequently predicted treatment non-participation. Positive and negative perceptions of this treatment modality were informative. Parents showed no differences in preference for individual or group CBT. An important finding was that 56% of the children had not received treatment since parental expression of interest in the group CBT program. Application of the findings to methods that promote service utilisation is discussed.

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Dakin, Helen A. "Economic evaluation of factorial randomised controlled trials". Thesis, University of Oxford, 2015. http://ora.ox.ac.uk/objects/uuid:77eda1f6-dd8c-439a-8871-75fd57a4c7f5.

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Factorial randomised controlled trials (RCTs) evaluate two or more interventions simultaneously, enabling assessment of interactions between treatments. This thesis presents literature reviews, methodological reviews, simulation studies and applied case studies that explore methods for assessing cost-effectiveness based on factorial RCTs. My systematic review suggests that factorial RCTs account for around 3% of trial-based economic evaluations, although there is currently no guidance or methodological work indicating the most appropriate methods. Around 40% of published studies assumed no interaction between treatments and many were poorly-reported. Various mechanisms are likely to produce large interactions within economic endpoints such as costs, quality-adjusted life-years (QALYs) and net benefits. Failing to take account of interactions can introduce bias and prevent efficient allocation of healthcare resources. I developed the opportunity cost of ignoring interactions as a measure of the implications of this bias. However, allowing for small, chance interactions is inefficient, potentially leading to over-investment in research if trial-based evaluations are used to inform decisions about subsequent research. Nonetheless, analyses on simulated trial data suggest that the opportunity cost of adopting a treatment that will not maximise health gains from the healthcare budget is minimised by including all interactions regardless of magnitude or statistical significance. Different approaches for conducting economic evaluations of factorial RCTs (including regression techniques, extrapolation using patient-level simulation, and considering different components of net benefit separately) are evaluated within three applied studies, including both full and partial factorials with 2x2 and 2x2x2 designs. I demonstrate that within both trial-based and model-based economic evaluation, efficient allocation of healthcare resources requires consideration of interactions between treatments, and joint decisions about interacting treatments based on incremental cost-effectiveness evaluated “inside-the-table” on a natural scale. I make recommendations for the design, analysis and reporting of factorial trial-based economic evaluations based on the results of this thesis.

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WANZIRA, HUMPHREY. "Supportive Supervision as an approach to improve the quality of care for children with acute malnutrition in Arua district, Uganda: Baseline systematic assessment, Cluster Randomised Controlled Trial and Cost-Effectiveness Analysis". Doctoral thesis, Università degli Studi di Trieste, 2019. http://hdl.handle.net/11368/2962380.

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INTRODUCTION Moderate and severe acute malnutrition estimates among children in the West Nile region, in Uganda, are higher than the national level (10.4% and 5.6%, respectively versus 3.6 % and 1.3 %). Additionally, the WHO estimates that in 2016, 6.6 million children and young adolescents died from causes attributed to the poor quality of care in such similar settings. Supportive supervision (SS) has been proposed as one of the approaches to improve quality of care. The main objectives of this project were; to determine the baseline status of the quality of care of nutrition services and health outcomes among malnourished children at health facility level; to test the effectiveness of supportive supervision to improve health outcomes and quality of care; and to estimate its cost effectiveness. METHODS Phase one: Six health centers with the highest burden of malnutrition in Arua district, West Nile region, were selected. Information on health outcomes (cured, defaulters, non responders, transferred and died) and quality of case management were extracted from official records. Quality of care was assessed using the national Nutrition Service Delivery Assessment (NSDA) tool, with ten key areas scored as poor, fair, good or excellent. Phase two: The six facilities were randomized to receive either SS or to control. SS was delivered for ten months in two equal five months’ periods; to heath center (HC) staff only (first period), and later extended to community health workers (CHWs) (second period). SS was delivered biweekly for the first three months and later monthly. The package included: monitoring progress, provision of technical support, facilitating good team dynamics and problem solving attitude. The control facilities were assigned to receive the national routine quarterly supervisory visits. Main outcomes included health outcomes, quality of case management, quality of nutrition service delivery and access to care. Phase three: The Incremental Cost Effectiveness Ratios (ICER) for the first and second period were estimated. RESULTS Phase one: A total of 1020 children were assessed at baseline. The cured and defaulter’s rates were 52.9% (95% CI: 49.7 – 56.1) and 38.3% (95%CI: 35.2 – 41.4) respectively. The NSDA revealed 33/60 (55%) areas scored poorly, 25/60 (41%) as fair, 2/60 (3.3%) were good and none were excellent. Main gaps included: lack of trained staff; disorganized patient flow; poor case management; stock out of essential nutrition supplies and weak community linkage. Phase two: 737 children were enrolled, 430 in the intervention and 307 in the control. Significant findings of the intervention versus control included: higher cure rate [83.8% (95%CI: 79.4 – 86.7) versus [44.9% (95%CI: 37.8 – 49.1), p=0.010)], lower defaulting rate [1.4% (95%CI 1.1% to 1.8%) versus 47.2% (95%CI 37.3% to 57.1 %), p=0.001], higher correct complementary treatment (94.0% versus 58.8%, p=0.001) and more NSDA areas scored as either good or excellent [24/30 (80%) versus 14/30 (46.6%), OR = 4.6 (1.3 – 17.4), p=0.007]. Access to care was significantly higher during the second period as compared to the first period [proportion difference = 28.4%, OR = 1.7 (1.3 – 2.3), p = 0.001].Phase three: the ICER of € 9.7 (95%CI:7.4 – 14.9) and € 6.8 (95% CI:4.8 – 9.5) were estimated in the first and second periods respectively. CONCLUSION At baseline, the quality of care provided to children with malnutrition at health center level was greatly substandard. The delivery of SS to HC staff and CHWs significantly improved the cure rate, the quality of case management, the overall quality of care and access to care. SS, especially that delivered to CHWs, was very cost effective.

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Littleton, Heather, Amie E. Grills, Katherine D. Kline, Alexander M. Schoemann e Julia Dodd. "The From Survivor to Thriver Program: RCT of an Online Therapist-Facilitated Program for Rape-Related PTSD". Digital Commons @ East Tennessee State University, 2016. https://dc.etsu.edu/etsu-works/7326.

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This study evaluated the efficacy of the From Survivor to Thriver program, an interactive, online therapist-facilitated cognitive-behavioral program for rape-related PTSD. Eighty-seven college women with rape-related PTSD were randomized to complete the interactive program (n = 46) or a psycho-educational self-help website (n = 41). Both programs led to large reductions in interview-assessed PTSD at post-treatment (interactive d = 2.22, psycho-educational d = 1.10), which were maintained at three month follow-up. Both also led to medium- to large-sized reductions in self-reported depressive and general anxiety symptoms. Follow-up analyses supported that the therapist-facilitated interactive program led to superior outcomes among those with higher pre-treatment PTSD whereas the psycho-educational self-help website led to superior outcomes for individuals with lower pre-treatment PTSD. Future research should examine the efficacy and effectiveness of online interventions for rape-related PTSD including whether treatment intensity matching could be utilized to maximize outcomes and therapist resource efficiency.

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Machai, Maria José Pires. "A school-based intervention for improving malaria-related knowledge and practices in Maputo Province, Mozambique : a randomised controlled trial". Master's thesis, University of Cape Town, 2008. http://hdl.handle.net/11427/3288.

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Includes abstract.
Includes bibliographical references (leaves 63-66).
The aim of the study was to evaluate the impact of a school-based malaria education intervention and its effectiveness in the changing knowledge and practices related to malaria at randomly selected schools in Maputo Province.

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Juriansz, A. "Conservative treatment of hallux valgus : a randomised controlled clinical trial of a hallux valgus night splint". Thesis, King's College London (University of London), 1996. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.541455.

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Nienhuis, Saskia Johanna. "Costs and effects of Doppler ultrasound measurements in suspected intrauterine growth retardation a randomised clinical trial /". Maastricht : Maastricht : Universitaire Pers Maastricht ; University Library, Maastricht University [Host], 1995. http://arno.unimaas.nl/show.cgi?fid=6637.

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Wiffen, Benjamin David Richard. "Online CBT for individuals with Christian beliefs : a pilot randomised controlled trial : and Clinical Research Portfolio". Thesis, University of Glasgow, 2014. http://theses.gla.ac.uk/5551/.

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Objectives: To investigate proof of concept, feasibility and efficacy of an online Cognitive Behavioural Therapy (CBT) intervention, modified to appeal to Christians who may be reluctant to access secular mental health services. Methods: 52 volunteers with Christian beliefs experiencing low mood or anxiety were recruited (median age=46.5, 25% male) to a pilot randomised waiting-list controlled trial of an online Spiritually-integrated CBT resource, with assessments at baseline, 8 weeks and 12 weeks. Primary outcome measures addressed mood, anxiety and general functioning. Results: No significant differences were found between groups on improvement of primary outcome measures, however there were non-significant trends in favour of those who had access to the course compared with waiting list control on all primary outcome measures. Conclusion: Online CBT targeted at religious groups may be an effective and practical means of promoting evidence-based psychological interventions to individuals who may not otherwise access them.

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GNESINI, Giulia. "REGULAR VERSUS RESCUE BUDESONIDE AND FORMOTEROL COMBINATION FOR MODERATE ASTHMA: A NON INFERIORITY RANDOMISED CLINICAL TRIAL". Doctoral thesis, Università degli studi di Ferrara, 2015. http://hdl.handle.net/11392/2389072.

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Wang, Yanyi, e s3042947@student rmit edu au. "Evaluation of effectiveness and safety of acupuncture in the treatment of migraine: A systematic review and a randomised controlled trial". RMIT University. Health Science, 2008. http://adt.lib.rmit.edu.au/adt/public/adt-VIT20091113.102639.

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Migraine affects 8 -16% of population in different countries resulting in significant economic and social impacts. Current pharmacological treatment provides symptomatic relief, but not without side effects. Hence, an increasing proportion of patients prefer complementary therapies including acupuncture for migraine relief. Randomised controlled trials (RCTs) of acupuncture treatment for migraine have produced conflicting evidence due to methodological and reporting deficiencies, including small sample sizes and inappropriate outcome measures. Furthermore, systematic reviews on acupuncture for headache failed to adequately represent non-English studies such as those conducted in China. This project aimed to: (1) systematically review studies of acupuncture for migraine; and (2) conduct a RCT addressing key deficiencies identified from the systematic reviews (SRs). Two SRs were conducted based onfollowing Cochrane review protocols. Major English, Chinese, Japanese and Korean databases were searched. The first SR included 15 English studies and the second SR had 17 Chinese studies. No Japanese or Korean RCTs were identified. Overall, those two SRs supported the value of acupuncture in the treatment and prevention of migraine when compared with western medications. However, conflicting results were found when real acupuncture treatments were compared with sham/placebo procedures. When compared with the studies published in English, Chinese studies had a higher frequency of acupuncture treatment, displayed poor methodological quality, and commonly used pharmacotherapy as a comparator. The SRs revealed that there was limited evaluation of acupuncture for frequent migraine. In the RCT, fifty participants with a minimum of eight migraine days per four weeks were randomly allocated to receive real (RA, n = 26) and sham (SA, n = 24) acupuncture for a total of 16 sessions over 20 weeks in a gradually decreasing treatment frequency. Fixed and supplementary acupoints were used. Participants were followed up for further assessment at three months and one year. Results showed that at the end of the treatment period, the mean (SD) migraine attack days per four weeks decreased from 11.81 (5.76) to 5.17 (5.02) in the RA group and from 12.41 (6.4) to 10.08 (7.11) in SA (group difference: p = .008). Intensity of migraine assessed using a Six-point Likert scale was lower in the RA (2.18 ±1.05) than that in the SA group (2.93 ± 0.61, p = 0.004). The percentile changes of pressure pain threshold (PPTs) detected at the bilateral points of TaiYang (Ex-HN5) were significantly higher in the RA group (RA 228.48% vs. SA -0.66 % on the left and 92.69% vs. -2.52% on the right). However, there was no s tatistically significant difference between the two groups with respect to Migraine Specific Quality of Life (MSQOL). At the end of the three-month follow up, medication consumption was less in the RA group, but not at the one-year follow up. In conclusion, this project demonstrates that acupuncture is a potentially effective and safe option for adult patients with frequent migraine headache with the effects lasting up to three months. Further studies are needed to confirm these therapeutic benefits with adequate sample sizes and the potential mechanism for this action.

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曾偉賢 e Wai-yin Tsang. "Analysis of data from a double-blind, placebo-controlled randomised clinical trial for the treatment of stroke". Thesis, The University of Hong Kong (Pokfulam, Hong Kong), 1993. http://hub.hku.hk/bib/B31977509.

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Tsang, Wai-yin. "Analysis of data from a double-blind, placebo-controlled randomised clinical trial for the treatment of stroke". Hong Kong : University of Hong Kong, 1993. http://sunzi.lib.hku.hk/hkuto/record.jsp?B13787007.

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Bagnall, Kara Marie. "Long-term follow-up of NetmumsHWD : a feasibility randomised controlled trial of telephone supported online behavioural activation for postnatal depression at 16 months post-randomisation". Thesis, University of Exeter, 2014. http://hdl.handle.net/10871/15289.

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Purpose: Postnatal depression has significant negative outcomes for both mother and baby. Cognitive-behavioural interventions have proven promising in its treatment, but there are a number of barriers, specific to the postnatal period, which lead to low take-up of treatment. Online interventions may circumvent some of these barriers. However, evidence of long-term follow-up is sparse, in spite of the importance of knowing how such treatments work over the longer-term. Methods: Long-term follow-up of postnatal women participating in a feasibility randomised controlled trial of NetmumsHWD, an online behavioural activation treatment with telephone support. Results: Retention rates of over 70 percent were obtained. There were small but non-significant effects of treatment on depressive symptomology and behavioural activation scores at 16 months post-randomisation. Baseline depression and behavioural activation scores predicted attrition prior to the implementation of outreach strategies for data collection; these systematic differences in attrition disappeared post-implementation. Measures of treatment adherence were not related to outcome. Conclusions: Collection of long-term follow-up data from postnatal women appears feasible. The findings demonstrate the importance of outreach in maximising retention, especially in relation to the generalizability of results. Future research should consider ways to assess treatment engagement and its relationship with outcome.

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Clough, Bonnie Anne. "Technological Adjuncts to Increase Adherence to Therapy: The Role of Mobile Phones". Thesis, Griffith University, 2016. http://hdl.handle.net/10072/366844.

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The aim of this thesis was to investigate the use of mobile phones as an adjunct to face-to-face psychotherapy. This aim was developed from two structured reviews of the literature concerning the types of adjunctive technologies in use, and the ways in which they have been used to increase adherence. Adjunctive use of the mobile phone was investigated in regards to its capacity to achieve greater client adherence and engagement in therapy, in order to facilitate improved treatment outcomes and client satisfaction. This overarching aim and hypothesis was investigated in three empirical studies, presented as a series of published and unpublished papers. Study One investigated the use of Short Message Service (SMS) appointment reminders. It was predicted that the SMS prompts, delivered the day prior to a scheduled appointment at an outpatient psychology clinic, would decrease client non attendance and dropout. In a Randomised Controlled Trial (RCT), 140 participants were allocated to either receive SMS appointment reminders or to receive no reminders. No significant differences were found between the two conditions in relation to client attendance. Dropout was higher in the SMS condition than in the no SMS condition. It was concluded that the SMS reminders did not increase client adherence to appointment attendance behaviours. This study also highlighted the importance of careful examination of technological interventions before dissemination.
Thesis (PhD Doctorate)
Doctor of Philosophy in Clinical Psychology (PhD ClinPsych)
School of Applied Psychology
Griffith Health
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Tagney, Jenny. "A randomised, clinical trial of a psycho-educational nursing intervention in patients receiving an Implantable Cardioverter Defibrillator". Thesis, University of the West of England, Bristol, 2013. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.601373.

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Implantable cardioverter defibrillators prevent Sudden Cardiac Death (SCD) in at-risk populations. Coming to terms with having an ICD, risk of SCD and a long-term condition may be impeded by negative psycho-social effects. Nurse-led psychoeducative support interventions have been trialled with mixed outcomes. As neither usual care or skills and knowledge of nurses delivering interventions were detailed, applicability within UK healthcare was unclear. This clinical trial tested a psychoeducational support intervention with usual care using arrhythmia clinical nurse specialists. Method Sixty-three people awaiting first ICD implant were randomised to usual care (n=33) or intervention (n=30) in one English cardiac centre between April 2009 and July 2011 . 'Treat-and-return' cases could not reliably access arrhythmia nurses preimplant and were therefore excluded. Participants completed validated self-report questionnaires (State Trait Anxiety Inventory-STAI; Beck Depression Inventory-Fast Screen- BDI-FS; COPE inventory; World Health Organisation Quality of Life tool- WHOQoL) pre-implant (T1), 6-weeks (T2) and 6-months (T3) post implant. The intervention was delivered 7-10 days post hospital discharge and following 6-week device check . 110 , Results Forty-nine participants (81 .6% male) completed pre-implant questionnaires (usual care n=25, intervention n=24) and 32/49 repeated these at T2 and T3. No significant differences were found between intervention and usual care groups postintervention. Both groups demonstrated increasing trait anxiety and altered coping over time (intervention group revealed increasing planning [p=0.037] and decreasing mental disengagement [p=0.008] but usual care group demonstrated increased denial [p=0.019]). At T3, denial significantly correlated with heightened state (r=0.573, p=0.010) and trait (r=0.577, p=0.010) anxiety for usual care, likewise BDIFS past failure (r=0.502, p=0.029 STAI-State; r=0.634, p=0.004 STAI-Trait) and selfcriticism (r=0.484, p=0.036 STAI-S; r=0.567, p=0.011 STAI-T). Conclusions and implications for practice Whilst small sample size limits generalisability, correlations between coping, anxiety and depression outcomes warrant further investigation with larger samples. Usual care for people having ICOs revealed inequitable access to psycho-educational support. Nurses are well placed to address these inequalities if appropriately resourced.

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Walker, Becky J. "A comparison of mandibular arch width changes using two different bracket systems : a randomised controlled clinical trial". Thesis, University of Bristol, 2014. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.681744.

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AIMS: The primary aim was to assess and compare mandibular arch width changes between self-ligating and non-self-ligating brackets using superelastic nickel titanium archwires. DESIGN: Single-centre prospective randomised controlled clinical trial. SETTING: Orthodontic department, Queen Alexandra Hospital, Portsmouth. PARTICIPANTS: 92 consecutive patients seen in the department who fulfilled the selection criteria. INTERVENTIONS: All patients were treated with upper and lower fixed appliances on a nonextraction basis. Patients were randomly assigned to Damon Q self-ligating or Orthos non-selfligating brackets in a ratio 1:1. Both groups received the same archwire sequence. Impressions were taken pre-treatment (TO) and 8 weeks after placement of the following archwires: 0.014// CuNiTi (TlL 0.014// x 0.025// CuNiTi (T2L 0.018// x 0.025// CuNiTi (T3). OUTCOME MEASURES: Intercanine, first and second interpremolar and intermolar widths were measured at all timepoints using digital callipers and a three-dimensional laser scanner. Perceived pain and anxiety levels were measured using questionnaires. Any breakages occurring during the study were recorded. RESULTS: There were statistically significant differences between Damon Q and Orthos in lower intercanine width at Tl (calliper p=0.031; laser p=O.017L T2 (calliper p=0.006; laser p=O.027) and T3 (calliper p=0.002; laser p=O.OOl); lower second interpremolar width at T3 (calliper p=0.009; laser p=0.009) and lower intermolar width at T3 (laser p=0.036). Orthos had the higher value for all of these differences. No findings were considered clinically significant. Pain scores were significantly higher for Orthos at TO, significantly higher for Damon at Tl, with no significant difference at T2. There was no significant difference in anxiety scores between the 2 groups. A record of breakages showed that Damon had more IIArchwire out// and Orthos 110 ring// failures than would be expected. CONCLUSION: There is no clinically significant difference between Damon Q self-ligating and Orthos non-self-ligating brackets in arch width changes when using superelastic nickel titanium archwires.

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Shore, Rob M. "A randomised controlled trial of an online mindfulness-based intervention for paranoia in a non-clinical population". Thesis, University of Surrey, 2015. http://epubs.surrey.ac.uk/808489/.

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Objectives : Paranoia is common in the general population and can impact on health, emotional well-being and social functioning; therefore effective interventions are needed. Brief online mindfulness-based interventions (MBIs) have the potential to be an easily accessible, low cost treatment for non-clinical populations. There is promising evidence for brief online MBIs for anxiety and depression however at present there is no research investigating whether they can benefit people with paranoia in the general population. Therefore the current study explored whether a brief online MBI increased levels of mindfulness and reduced levels of paranoia in a non-clinical population. The mediating effect of mindfulness on any changes in paranoia was also investigated. Method: 110 participants were randomly allocated to either a two week online MBI involving 10 minutes of daily guided mindfulness practice or to a waitlist control condition. Measures of mindfulness and paranoia were administered at baseline, post-intervention and one-week follow-up. Results: Analysis of the data indicated that there were significant group by time interactions for levels of paranoia and mindfulness skills. Participants in the MBI group displayed significantly greater reductions in paranoia and increases in mindfulness when compared to the waitlist control group. Mediation analysis demonstrated that change in mindfulness skills mediated the relationship between intervention type and change in levels of paranoia. Conclusions: This study provides evidence that a brief online MBI can increase mindfulness skills and significantly reduce levels of paranoia in a non-clinical population. Furthermore, increases in mindfulness skills from this brief online MBI can mediate reductions in non-clinical paranoia. The limitations and clinical implications of this study are discussed.

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Sadler, Paul. "Cognitive behaviour therapy for insomnia and depression among older adults : A mixed methods randomised controlled clinical trial". Thesis, Federation University Australia, 2018. http://researchonline.federation.edu.au/vital/access/HandleResolver/1959.17/168037.

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Background A strong relationship exists between insomnia and depression, particularly among older adults (aged 65 years and older). Recently experts in the field of behavioural sleep medicine established cognitive behaviour therapy (CBT) was an effective treatment for comorbid insomnia, however, it was unknown whether cognitive behaviour therapy for insomnia (CBT-I) benefitted older adults with co-occurring depression (literature review published in Cognitive Behaviour Therapy). A mixed-methods randomised controlled clinical trial (RCT) was warranted within a community mental health setting to investigate the efficacy of CBT-I for older adults with comorbid insomnia and depression. Furthermore, no study had tested whether an advanced form of CBT-I that included additional positive mood-enhancing strategies produced better outcomes compared to a standard form of CBT-I that only targeted insomnia. It was anticipated that the results from such a trial could influence the evolution of treatment for older adults with these highly prevalent comorbid conditions. Methodology An RCT was conducted between 2014 and 2016 across Victoria, Australia, through Latrobe Regional Hospital‟s and Peninsula Health‟s Community Mental Health Services (protocol published in Trials). Seventy-two older adults with diagnosed comorbid insomnia and depression were randomly assigned to one of three group therapy conditions: cognitive behaviour therapy for insomnia (CBT-I, standard), cognitive behaviour therapy for insomnia plus positive mood strategies (CBT-I+, advanced), psychoeducation control group (PCG, control). The primary outcomes were insomnia severity (Insomnia Severity Index) and depression severity (Geriatric Depression Scale). Primary and secondary measures were collected at pre (week 0), post (week 8), and follow-up (week 20). Participants who completed the experiential conditions were invited to provide feedback in the form of semi- xvii structured focus groups following the final session of treatment. Thirty-one participants from six groups reflected on their experiences of participating in CBT-I and CBT-I+. Results Quantitative analyses demonstrated the experiential CBT conditions both generated significantly greater reductions in insomnia and depression severity compared to PCG from pre to post, which were maintained at follow-up. The standard and advanced conditions showed similar reductions on insomnia and depression severity at post and follow up. These results were also consistent for the secondary measures across conditions. Both active treatments demonstrated large effect sizes, high retention, and strong remission rates for older adults with insomnia and depression (published in journal SLEEP). A qualitative analysis was also conducted to explore the participants‟ experiences of treatment. Interview data from the reflective focus groups was transcribed into 424 sentences and 60 codes were extracted. Thirty-four initial themes emerged, which were finally transformed into 3 themes and 10 subthemes. The three themes were (1) positive experiences, (2) negative experiences, and (3) suggested modifications. The positive subthemes were (1a) therapists, (1b) togetherness, (1c) use of strategies reduced symptoms, and (1d) acceptance. The negative subthemes were (2a) persistent symptoms, (2b) program too condensed, and (2c) attendance obstacles. The suggested modifications were (3a) lengthen program, (3b) multi-dimensional learning, and (3c) multi-modal delivery options (manuscript under review in Aging and Mental Health). Conclusion This is the first RCT to demonstrate that specifically treating comorbid insomnia with CBT has an additional positive effect of improving depression for older adults with multiple comorbidities. Both CBT programs were effective at reducing insomnia and depression severity for older adults with comorbidity. Replication of this study is necessary with a larger sample size to conclusively establish whether the two interventions have different or equivalent effects. It was suggested mental health services that deliver treatment for comorbid insomnia with CBT may improve recovery outcomes for older adults with depression. Future CBT-I programs for older adults may be improved by increasing the length of therapy (e.g., 8 sessions to 12 sessions), adding multi-dimensional learning opportunities (e.g., visual/audio/mentorship), and offering various modes of treatment delivery (e.g., group, individual, internet, telephone).
Doctor of Philosophy

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47

Williams, Catherine Elizabeth Mary. "A randomised controlled trial comparing two approaches to preschool vision screening in children under the age of 37 months". Thesis, University of Bristol, 1997. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.285811.

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48

Russell, Trevor G. "Establishing the efficacy of telemedicine as a clinical tool for physiotherapists : from systems design to randomised controlled trial /". [St. Lucia, Qld.], 2004. http://adt.library.uq.edu.au/public/adt-QU20040608.114117/index.html.

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49

Toth, Benjamin. "Clinical trials in British medicine 1858-1948, with special reference to the development of the randomised controlled trial". Thesis, University of Bristol, 1998. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.364843.

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50

Haynes, Richard. "The safety, tolerability and biochemical efficacy of extended release niacin and laropiprant in a major randomised clinical trial". Thesis, University of Oxford, 2013. http://ora.ox.ac.uk/objects/uuid:01ba360a-fe6a-4a1a-ba14-48a2dcc3e0dd.

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Niacin has been in clinical use for over 50 years and was the first drug shown in a randomized trial to improve outcomes after MI, but substantial uncertainty remains about its efficacy and safety in the context of current standard medical therapy. This thesis explores the biochemical efficacy, tolerability and safety of extended release (ER) niacin/laropiprant in the large, randomized HPS2-THRIVE trial. Laropiprant is a prostaglandin D₂ receptor (DP1) antagonist which reduces the main adverse effect of niacin, namely “flushing” (an unpleasant cutaneous vasodilation) that makes a large trial of niacin practicable. ER niacin/laropiprant increases high density lipoprotein cholesterol (HDL-C) and apolipoprotein A1, and reduces low density lipoprotein cholesterol (LDL-C), apolipoprotein B, triglycerides and lipoprotein (a), consistent with previous studies of ER niacin. The reasons for stopping ER niacin/laropiprant reflected the known adverse effect profile of ER niacin, although unlike previous trials flushing was not the most frequent reason for stopping. Skin (pruritus and rash), gastrointestinal (nausea, pain and diarrhoea) and diabetes-related (hyperglycaemia) adverse events were the most common reasons for stopping ER niacin/laropiprant during 3.9 years’ follow-up. The analyses presented here identified three major previously unknown hazards of ER niacin. ER niacin/laropiprant increased the risk of statin-related myopathy almost five-fold, and this effect was greater among participants in China than Europe. ER niacin/laropiprant also increased the risk of bleeding (intracranial, gastrointestinal and other sites) and infection. Compared to placebo there was an absolute excess of 3.1% of serious adverse events (excluding cancer and major vascular events [MVEs]) among participants assigned ER niacin/laropiprant. ER niacin/laropiprant did not significantly reduce MVEs. These findings suggest that the use of niacin to reduce vascular risk should now be reconsidered.

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